Überblick über die Statistik des Gehaltsniveaus für "Site Operations Manager in Deutschland"

Location: Poland - Home based        Schedule: Freelance, Various FTEs                                    CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Project Manager I, to join their clinical operations team in Poland. This is a full-time opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                      As a Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects.   Join our team and help us deliver clinical trials that will improve patients' lives.                   Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators and coordinating the project team memberOversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical stateManages the budget of the projectParticipates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the SponsorSupervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulationsUndertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levelsMay provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activitiesSupervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projectsMay act as Feasibility Associate (FEA) after appropriate and documented trainingMay prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them Education and Experience:University Degree in scientific, medical, or paramedical disciplinesUp to three 3 years of project management experience in the CRO/Pharmaceutical industryStrong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel The Application Process   Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.        If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.      Who will you be working for?      About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                      Our Company Ethos   Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.      CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.      Keywords: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation  Skills: Clinical Project Manager, Clinical Study Manager, clinical trials, ICH-GCP, Project Management, EnglishLocation: PolandShare: LinkedIn Facebook Twitter Email

&Solution Adoption Manager (m/f/d) SAP S/4HANA Treasury & FIVorwerk Services GmbH provides IT services for the Vorwerk Group. The Vorwerk Group, which is still a family-owned company, is one of the largest direct sales companies worldwide. Vorwerk´s core business is the production and sale of innovative premium household appliances. The portfolio also consists of commercial cleaning, financing solutions as well as a venture capital company. Today, the globally active Vorwerk Group has around 11,000 employees in over 60 countries.Your responsibilities: Functional responsibility for the successful implementation of our current S/4HANA Treasury project initiatives (TRM, CM, IHC, MBC, SAC) and FI initiatives Management of our external partners for the Treasury IT service and further project initiatives Management of the demand process for further system changes in Treasury and FI Overseeing the design of the S/4HANA Treasury solutions, including the integration with other SAP modules and external Treasury Systems (Market Data provider, Matching Service, Trading Platform)You offer us: Founded experience in working in IT projects as (inhouse) consultant with (SAP) Treasury and/or SAP FI Proven prior experience performing software implementation responsibilities and functions Proven prior experience in service operation and service transition based processes. ITIL knowledge welcome Understanding of direct sales processes and procedures welcome Deep understanding in the areas of (SAP) Treasury and/or SAP FI, basic knowledge in SAP MBC and SAC solutions, other SAP modules as well as SAP integration platforms welcome Strong interpersonal and intercultural skills Fluent knowledge of business English and GermanWe offer you: Flexible working framework through flexitime, flextime days and 30 days of holiday Possibility of mobile working within a defined framework Attractive pension plan through several modules as well as the option of a time value account Benefits of a family-owned company such as employee discounts, subsidy for childcare costs as well as tariff-oriented remuneration in accordance with the metal and electrical industry of NRW Internal and external training opportunities Extensive health benefits such as supplementary company health insurance, a wide range of fitness options and the possibility of on-site physiotherapy Subsidized snacks and menus Discounted job ticket and free parking directly at the workplaceYour contact:Vorwerk Services GmbHMühlenweg 17-3742270 Wuppertalhttps://www.vorwerk-group.com/de/home Über das Unternehmen:Vorwerk Services GmbHBranche:Konsumgüter/Kosmetik

Site Manager*Position contingent upon award*Location: Germany – U.S. Government InstallationsContinuity Global Solutions (CGS) is pursuing a contract with a U.S. federal government agency to provide security at U.S. Army installations throughout Germany. Armed security personnel will provide static installation access control, roving security patrols, intrusion detection system monitoring, pass and badge control, static personal security and other security related functions as required. The armed security personnel will provide protection of U.S. Government installations, materials, property, and personnel.As part of this effort, CGS is looking for experienced Site Managers. The Site Managers will be responsible for the management and performance of the guard force at an assigned U.S. Army installation(s) and any satellite areas associated with the installation(s).Responsibilities:Responsible for effectively managing security operations and for Contractor (CGS) performance at assigned U.S. Army installationsPerforms direct line management of the armed guards assigned to the military installation(s)Responsible for quality control and for ensuring contract compliancePerforms accurate and detailed reporting Responsible for liaising with the client and with German authoritiesRequirementsSecurity or law enforcement administration experience in the armed forces, civilian police or commercial security agenciesThe above experience should demonstrate the capability to manage a program of comparable scope and magnitude (multiple guard teams operating simultaneously at different installations)Leadership experienceProject/program management experienceExperience managing armed security personnelExpertise in all areas of physical security and access controlComputer literacy, including the ability to use all common office management tools (e.g., Microsoft Office)Experience in basic communications and radio use/proceduresSecondary education or national diplomaMinimum five years of police, military and/or security management experience at the manager, supervisor or commander levelsMinimum two years of work experience in Germany)Intimate knowledge of overseas security environments and familiarity with specific threats in GermanyRisk management skills, including problem identification, risk management planning, qualitative risk analysis and problem solvingiability and good conduct on past assignmentsDesired Education & Experience:Secondary education or national diplomaMinimum five years of police, military and/or security management experience at the manager, supervisor or commander levelsMinimum two years of work experience in Germany)Intimate knowledge of overseas security environments and familiarity with specific threats in GermanyRisk management skills, including problem identification, risk management planning, qualitative risk analysis and problem solvingOther Required Qualifications:Professional fluency in both English & GermanMust be familiar with applicable U.S. military regulations and German lawsMust be a native-born citizen of a NATO-member country or a U.S. citizen (native-born or naturalized). Non-U.S. citizens are permitted only if they are ex-U.S. military or if they are a current U.S. military spouse/family member. Active-duty service members are not eligible.Must meet, or be eligible to meet, security criteria in accordance with AER 190-16 requirements, AE Form 604-1A and 604-1B, IAW AE Regulation 604-1, Local National Screening Program in Germany (LNSP)Must be able to pass a background check (e.g., European Police Good Conduct Certificates (EPGCC) for EU citizens or a German PGCC; a National Crime Information Center (NCIC) Check – Interstate Identification Index (NCIC-III) for U.S. citizens; or AE Form 190-45D for U.S. military family members/DoD civiliansMust be a resident of Germany for 12 consecutive months at the time of contract awardMust be willing to sign a Letter of Commitment with CGSMust be capable of maintaining a professional demeanor under highly stressful circumstancesMust have a verifiable record of proven reliability and good conduct on past assignmentsRequirementsSecondary education or national diplomaMinimum five years of police, military and/or security management experience at the manager, supervisor or commander levelsMinimum two years of work experience in Germany)Professional fluency in both English & GermanMust be familiar with applicable U.S. military regulations and German lawsMust be a native-born citizen of a NATO-member country or a U.S. citizen (native-born or naturalized). Non-U.S. citizens are permitted only if they are ex-U.S. military or if they are a current U.S. military spouse/family member. Active-duty service members are not eligible.Must meet, or be eligible to meet, security criteria in accordance with AER 190-16 requirements, AE Form 604-1A and 604-1B, IAW AE Regulation 604-1, Local National Screening Program in Germany (LNSP)Must be able to pass a background check (e.g., European Police Good Conduct Certificates (EPGCC) for EU citizens or a German PGCC; a National Crime Information Center (NCIC) Check – Interstate Identification Index (NCIC-III) for U.S. citizens; or AE Form 190-45D for U.S. military family members/DoD civiliansMust be a resident of Germany for 12 consecutive months at the time of contract awardMust be willing to sign a Letter of Commitment with CGSMust be capable of maintaining a professional demeanor under highly stressful circumstancesMust have a verifiable record of proven reliability and good conduct on past assignmentsÜber das Unternehmen:Continuity Global Solutions

Site Manager*Position contingent upon award*Location: Germany – U.S. Government InstallationsContinuity Global Solutions (CGS) is pursuing a contract with a U.S. federal government agency to provide security at U.S. Army installations throughout Germany. Armed security personnel will provide static installation access control, roving security patrols, intrusion detection system monitoring, pass and badge control, static personal security and other security related functions as required. The armed security personnel will provide protection of U.S. Government installations, materials, property, and personnel.As part of this effort, CGS is looking for experienced Site Managers. The Site Managers will be responsible for the management and performance of the guard force at an assigned U.S. Army installation(s) and any satellite areas associated with the installation(s).Responsibilities:Responsible for effectively managing security operations and for Contractor (CGS) performance at assigned U.S. Army installationsPerforms direct line management of the armed guards assigned to the military installation(s)Responsible for quality control and for ensuring contract compliancePerforms accurate and detailed reporting Responsible for liaising with the client and with German authoritiesRequirementsSecurity or law enforcement administration experience in the armed forces, civilian police or commercial security agenciesThe above experience should demonstrate the capability to manage a program of comparable scope and magnitude (multiple guard teams operating simultaneously at different installations)Leadership experienceProject/program management experienceExperience managing armed security personnelExpertise in all areas of physical security and access controlComputer literacy, including the ability to use all common office management tools (e.g., Microsoft Office)Experience in basic communications and radio use/proceduresSecondary education or national diplomaMinimum five years of police, military and/or security management experience at the manager, supervisor or commander levelsMinimum two years of work experience in Germany)Intimate knowledge of overseas security environments and familiarity with specific threats in GermanyRisk management skills, including problem identification, risk management planning, qualitative risk analysis and problem solvingiability and good conduct on past assignmentsDesired Education & Experience:Secondary education or national diplomaMinimum five years of police, military and/or security management experience at the manager, supervisor or commander levelsMinimum two years of work experience in Germany)Intimate knowledge of overseas security environments and familiarity with specific threats in GermanyRisk management skills, including problem identification, risk management planning, qualitative risk analysis and problem solvingOther Required Qualifications:Professional fluency in both English & GermanMust be familiar with applicable U.S. military regulations and German lawsMust be a native-born citizen of a NATO-member country or a U.S. citizen (native-born or naturalized). Non-U.S. citizens are permitted only if they are ex-U.S. military or if they are a current U.S. military spouse/family member. Active-duty service members are not eligible.Must meet, or be eligible to meet, security criteria in accordance with AER 190-16 requirements, AE Form 604-1A and 604-1B, IAW AE Regulation 604-1, Local National Screening Program in Germany (LNSP)Must be able to pass a background check (e.g., European Police Good Conduct Certificates (EPGCC) for EU citizens or a German PGCC; a National Crime Information Center (NCIC) Check – Interstate Identification Index (NCIC-III) for U.S. citizens; or AE Form 190-45D for U.S. military family members/DoD civiliansMust be a resident of Germany for 12 consecutive months at the time of contract awardMust be willing to sign a Letter of Commitment with CGSMust be capable of maintaining a professional demeanor under highly stressful circumstancesMust have a verifiable record of proven reliability and good conduct on past assignmentsRequirementsSecondary education or national diplomaMinimum five years of police, military and/or security management experience at the manager, supervisor or commander levelsMinimum two years of work experience in Germany)Professional fluency in both English & GermanMust be familiar with applicable U.S. military regulations and German lawsMust be a native-born citizen of a NATO-member country or a U.S. citizen (native-born or naturalized). Non-U.S. citizens are permitted only if they are ex-U.S. military or if they are a current U.S. military spouse/family member. Active-duty service members are not eligible.Must meet, or be eligible to meet, security criteria in accordance with AER 190-16 requirements, AE Form 604-1A and 604-1B, IAW AE Regulation 604-1, Local National Screening Program in Germany (LNSP)Must be able to pass a background check (e.g., European Police Good Conduct Certificates (EPGCC) for EU citizens or a German PGCC; a National Crime Information Center (NCIC) Check – Interstate Identification Index (NCIC-III) for U.S. citizens; or AE Form 190-45D for U.S. military family members/DoD civiliansMust be a resident of Germany for 12 consecutive months at the time of contract awardMust be willing to sign a Letter of Commitment with CGSMust be capable of maintaining a professional demeanor under highly stressful circumstancesMust have a verifiable record of proven reliability and good conduct on past assignmentsÜber das Unternehmen:Continuity Global Solutions

&Senior Solution Adoption Manager (m/f/d) Central Business Applications VIA ReleasemanagementVorwerk Services GmbH provides IT services for the Vorwerk Group. The Vorwerk Group, which is still a family-owned company, is one of the largest direct sales companies worldwide. Vorwerk´s core business is the production and sale of innovative premium household appliances. The portfolio also consists of commercial cleaning, financing solutions as well as a venture capital company. Today, the globally active Vorwerk Group has around 11,000 employees in over 60 countries.Your responsibilities: Plan, execute and implement major and minor Business releases in SAP and Non-SAP with suppliers Support interface design and implementation of Application integration using SAP Integration suite or Mule ESB Business Demand Management for SAP and non – SAP solutions Design and Governance for a SAP and non - SAP solutions Support Releases as a cutover manager Support the Lead Service Manager in Service operation processesYou offer us: Founded experience in working in IT projects as a Consultant in Release and Deployment Management for a SOA Architecture with Java Business Applications, ESB Mule and SAP ERP Proven prior experience performing software implementation with Solution architect responsibilities and functions Proven prior experience in Service operation and Service transition ITIL based processes Understanding in Software deployment and Release Management processes, SAP and non-SAP Strong interpersonal and intercultural skills Business fluent knowledge of English and German Experience in agile methods and DEVOPS are welcomeWe offer you: Flexible working framework (through flexitime, flextime days) and 30 days of holiday Possibility of mobile working within a defined framework Attractive pension plan through several modules as well as the option of a time value account Benefits of a family-owned company such as employee discounts, subsidy for childcare costs as well as tariff-oriented remuneration in accordance with the metal and electrical industry of NRW Internal and external training opportunities Extensive health benefits such as supplementary company health insurance, a wide range of fitness options and the possibility of on-site physiotherapy Subsidized snacks and menus Discounted job ticket and free parking directly at the workplaceYour contact:Vorwerk Services GmbHMühlenweg 17-3742270 Wuppertalhttps://www.vorwerk-group.com/de/home Über das Unternehmen:Vorwerk Services GmbHBranche:Konsumgüter/Kosmetik

Location: Italy - Home or office based      Schedule: Permanent, Full-time                 Do you want to join a team that is passionate about making a difference in drug and medical device development?  CROMSOURCE, a growing CRO, is recruiting for a Senior Clinical Project Manager to join their clinical operations team. This is a permanent opportunity in Italy. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                          As a Senior Clinical Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects. Previous experience with respiratory and oncology trials is preferred. A minimum of 3 years of experience with a CRO is needed.           Join our team and help us deliver clinical trials that will improve patients' lives.                               Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators, and coordinating the project team members.Oversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical state.Manages the budget of the project.Participates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor.Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels.May provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activities.Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projects.May act as Feasibility Associate (FEA) after appropriate and documented training.May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them. Education and Experience Required:University Degree in scientific, medical, or paramedical disciplines with 3 years of experienceSignificant 3 years of experience in clinical project management in the CRO/pharmaceutical industryExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel. The Benefits of Working in Italy:· Meal vouchers· Mobile phone if requested by the Line Manager· Dedicated Line Manager Who will you be working for?                                    About CROMSOURCE                       CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                                                    Our Company Ethos                  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they can develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry average turnover rates.                                     The Application Process                  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.               If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.                                        CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.                                     Keywords: Project Manager, Clinical Project Manager, CRO, Clinical Research Organisation, Contract Research Organisation, Clinical, Drugs, Medical Devices, Medical Device, Project Management, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, Respiratory, Oncology, OphthalmologySkills: Clinical Project Manager, Clinical Study Manager, Clinical Trial Manager, Senior Clinical Project Manager, clinical trials, CRO, Medical Devices, Study ManagementLocation: ItalyShare: LinkedIn Facebook Twitter Email

Location: Spain - Home-based          Schedule: Permanent, Full-time                         Do you want to join a team that is passionate about making a difference in drug and medical device development?  CROMSOURCE, a growing CRO, is recruiting for a Senior Clinical Project Manager to join their clinical operations team. This is a permanent opportunity in Spain. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                                  As a Senior Clinical Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects. Previous experience with respiratory and oncology trials is preferred. A minimum of 3 years of experience with a CRO is needed.                   Join our team and help us deliver clinical trials that will improve patients' lives.                                         Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators, and coordinating the project team members.Oversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical state.Manages the budget of the project.Participates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor.Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels.May provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activities.Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projects.May act as Feasibility Associate (FEA) after appropriate and documented training.May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them. Education and Experience Required:University Degree in scientific, medical, or paramedical disciplines with 3 years of experienceSignificant 3 years of experience in clinical project management in the CRO/pharmaceutical industryExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel  The Benefits of Working in Spain:Competitive SalaryHealth insuranceHome office allowanceMeal vouchers23 days of holiday per yearDedicated Line Manager Who will you be working for?                                             About CROMSOURCE                            CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                                                              Our Company Ethos                       Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they can develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry average turnover rates.                                             The Application Process                       Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.                       If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.                                                  CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.                                             Keywords: Project Manager, Clinical Project Manager, CRO, Clinical Research Organisation, Clinical, Drugs, Medical Devices, Medical Device, Project Management, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, Respiratory, Oncology, OphthalmologySkills: Clinical Project Manager, Clinical Study Manager, Clinical Trial Manager, Senior Clinical Project Manager, Senior Clinical Trial Manager, clinical trials, CRO, Medical Devices, Study ManagementLocation: SpainShare: LinkedIn Facebook Twitter Email

Location: Germany- Home or office based      Schedule: Permanent, Full-time                 Do you want to join a team that is passionate about making a difference in drug and medical device development? CROMSOURCE, a growing CRO, is recruiting for a Senior Clinical Project Manager to join their clinical operations team. This is a permanent opportunity in Germany. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.                          As a Senior Clinical Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects. Previous experience with respiratory and oncology trials is preferred. A minimum of 3 years of experience with a CRO is needed.           Join our team and help us deliver clinical trials that will improve patients' lives.                                 Main Tasks and Responsibilities:Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators, and coordinating the project team members.Oversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical state.Manages the budget of the project.Participates in Monitor's and Investigator's MeetingsProvides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor.Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations.Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels.May provide oversight and mentoring for junior staff assigned to the projects.Supervises the archiving activities.Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)Performs, if necessary, co-monitoring visits for the assigned clinical projects.May act as Feasibility Associate (FEA) after appropriate and documented training.May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them. Education and Experience Required:University Degree in scientific, medical, or paramedical disciplines with 3 years of experienceSignificant 3 years of experience in clinical project management in the CRO/pharmaceutical industryExcellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirementsFluent in English and local language(s)Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)Willingness to travel. The Benefits of Working in Germany:30 Euro net Internet cost reimbursement per monthAdditional Accident Insurance, fully covered by the company.25 vacation daysPossibility of salary conversion for additional pension insuranceDedicated Line ManagerMonthly meetings with the line managerFull performance and development process with end-of-year reviewsTeam events and end-of-year partyCareer opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationallyEmployee satisfaction survey - your feedback is important for continuous improvement. Who will you be working for?                                    About CROMSOURCE                        CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                                                      Our Company Ethos                  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they can develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry average turnover rates.                                     The Application Process                  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.               If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.                                          CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.                                     Keywords: Project Manager, Clinical Project Manager, CRO, Clinical Research Organisation, Contract Research Organisation, Clinical, Drugs, Medical Devices, Medical Device, Project Management, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, Respiratory, Oncology, OphthalmologySkills: Clinical Project Manager, Clinical Trial Manager, clinical trials, CRO, Medical Devices, Project Leadership, Project ManagementLocation: GermanyShare: LinkedIn Facebook Twitter Email

Pilot Plant Manager Location: Lubeck, Germany Team: Technical As Pilot Plant Manager, you will be the lead for the Pilot Plant in Luebeck, our Customer Innovation & Collaboration Center (CI&CC), including facility, driving the pilot and facility team, managing the machines and equipment for actual and future needs to collaborate efficiently with our customers. You will network with our technical community to get our CI&CC set for the present and future challenges. You are ensuring that the building's technical installations, safety technology, machines and equipment function properly, taking into account and complying with the legal and technical requirements, as well as the requirements of Tate & Lyle. You will manage and plan the deployment of employees in the facility and technical center area (approx. 10 employees) as well as process and cost optimization. Tasks & responsibilities Operations management Manage health, safety, food safety, hygiene and environmental conditions at pilot level and facility level; work closely with the Safety officer Plans the overall allocation of human and material resources, as well as production’s agenda and general organizational procedures Makes investment propositions Ensuring that the Quality culture and compliance with Quality procedures are integrated Ensure the maintenance and availability of equipment. Implementing a continuous improvement approach to improve processes, people development and equipment. Strategy Connect and work transversally with technical leads (Technical Service and Application), in terms of planning efficiently short/medium/long term activities of the teams, and transformation needs of the premise to fulfill the strategies Facility Management Ensure building’s technical installation, safety technology run and comply with the legal and technical requirements incl. document management, as well as the requirements of Tate & Lyle. Manage of the service contractors, 3rd party vendors and long-term leasers and agreed contracts with the support of the Global purchaser team and on-site facility team Responsible for relations and contracts with tenants In charge of fire safety on site with vendors support, relation with fire brigade and insurer Ensure all works carried out are completed in a safe and controlled manner adhering with legislation Finance Work closely with the Technical Service Director Europe, and others key stakeholders to ensure accurate forecasting, close management and controlling of the budgets (Monthly - Quarterly and Annually) Ensure budgets for works are closely managed and each project is delivered in line with the assigned project and time scales Project Management - Policy Implementation & EHSQS Journey Review Operational procedures, ensure the teams are working efficiently, complying with our EHSQS standards (using our internal audits system); provide continuous feedback on best practice and safe working systems Where required support with the creation and roll out of new initiatives and projects to optimize process and costs, maintain/improve standards and safety requirements Ensure the food safety and the legal compliance is being achieved with EHSQS team support Take a proactive approach towards your own team and your own continuous development in line with legislation and operational best practice. Work closely with your direct reports to ensure our values are alive and kicking Qualifications Have an Engineering or Technical (Food Production / Food Safety) diploma. Experience managing and understanding of Safety legislation and Food Safety Have experience of managing team Experience managing outsourced contractors Preventative Maintenance Safety compliance (fire alarms, water hygiene, lifts, fire extinguishers, F&B etc.). Fluent in German & English Networking, communication, organization and project management skills It would be preferred if you have certificates for a qualified electrician and fire safety officer What we can offer you A competitive salary Bonus opportunity Unlimited Contract Holiday pay and 13th salary 40 € per month for a private pension plan 30 days annual leave Flexible working hours Job bike / company fitness On-site canteen and free water, coffee, tea without end, as well as muesli and milk Good free parking facilities Are you interested? Then we look forward to receiving your application on our careers page. Tate & Lyle is an equal opportunity employer, committed to the strength of an inclusive workforce. Our purpose, Improving Lives for Generations, inspires everything we do. Whether it’s by making food and drink healthier and tastier; continuously improving how we work; promoting a safe working environment; or making a difference to our local communities, we believe we can successfully grow our business and have a positive impact on society. Our work is driven by consumer health needs and trends, governments desire to build and support healthy communities, and the need for affordable food and nutrition in many parts of the world. We deliver ingredients and solutions to meet all these needs. Our speciality sweeteners and fibres help reduce sugar and calories. Our fibres enrich food and improve digestive health. Our texturants and stabilising systems help extend shelf-life and make food manufacturing easier. Our bulk sweeteners deliver great tasting products at an affordable cost. And our industrial starches give strength to the packaging used to deliver online goods to millions of homes every day. Across the globe, we are Improving Lives for Generations. And all our talented and skilled people help us on this journey. Want to know more? Take a look here.Über das Unternehmen:5116 G. C. Hahn & Co. Stabilisierungstechnik GmbH

Walker Cole International is searching for a Senior Quality Assurance (QA) Manager to join a leading Pharmaceutical business in the Saxony region. The role holder will be responsible for ensuring GMP (Good Manufacturing Practice) is maintained across site operations, and maintain contact with the regulator to ensure activities are in compliance with all relevant regulatory guidelines.Your responsibilities will be to:Lead the Quality Operations on site, ensuring Good Manufacturing Practice (GMP) is maintained.Maintain and improve existing quality processes to ensure continuous operational compliance.Strategically plan both internal and external audits and complete the internal audits as per the annual schedule.Host regulatory audits from ANVISA, FDA, EMA, ZMA, Russian Authorities.Facilitate actions and maintain compliance to the systems for change controls, Corrective and Preventive Actions (CAPA's), deviations and complaints.Lead operational QA activities including investigating deviations, root cause analysis and batch record review. The successful Quality Manager will have:5 + years of experience in Quality Assurance within the Pharmaceutical and Life Sciences industry.Strong working knowledge of GxP requirements.Experience managing a team of QA professionals in a commercial manufacturing environment.Quality Assurance | QA | Pharmaceutical | CAPA | Corrective and Preventative Action | Quality | eQMS | PQS | Pharmaceutical Quality System | Batch Release | GMP | Good Manufacturing Practice | QMS | Quality Management System | GxP | Audit | Manager | Team Lead | ANVISA | FDA | EMA | ZMA | Change Control | Deviation | Root Cause Analysis | GEMBA | Oral Solid Dose | Tablets | Capsules | Steriles | Aseptic | Inhaled | Biologics | Biopharmaceutical | VaccineÜber das Unternehmen:Walker Cole InternationalBranche:Pharma - (Liquids / Semi-solid)

ABOUT NUMAHey! We're numa. We're a dynamic, diverse hospitality brand that's offering uniquely designed apartments for the modern traveler. We specialize in the beauty of convenience and the delight of a design, with a totally digital guest experience and properties designed with intention. Numa properties are located in the most exciting and vibrant neighbourhoods across Europe. We're not just disrupting the hospitality industry for our guests—behind the curtain, we're shaking up the way hotels operate. We've built a proprietary technology and data platform that makes running a hospitality operation more efficient than ever. We offer consistent quality and an unmatched guest experience. About the role Working within the project management team (alongside design and real estate) you will be an integral part of our company, shaping our physical product and ensuring exceptional execution and guest experience. Being involved in the due diligence, planning and delivery of our take-over, refurbishment and development projects your tasks will include: Technical due diligence:Executing inspections of potential new locations Evaluating the condition of the existing systems - HVAC, electrical, plumbing, fire safety, and other MEP componentsIdentify deficiencies, repairs, upgrades, and estimate the timelines and associated costs Analyzing existing plans and reports Evaluate the Feasibility of implementing numa standards Prepare reports outlining the findings, recommendations, and potential risks - red flags in regards to MEPReview the MEP-related documentation provided by the landlord, such as MEP design drawings, specifications, equipment manuals, and maintenance records.Verify the completeness and accuracy of the MEP documentation and assess its compliance with your company's standards and requirementsIdentify any gaps or discrepancies in the documentation and coordinate with the LL to resolve them During planning: Collaborate with architects and designers to develop MEP concept plans that align with numa standards and requirementsReview, evaluation and approvals of the MEP drawings, specifications, calculations for MEP systems, including the description of project-related services provided by the engineering consultants/contractorsCoordinate with the design and development team to ensure the MEP designs are integrated into the overall project plans Address any non-compliance issues promptly and work with contractors to resolve them.Provide input and recommendations for value engineering and cost-saving opportunities within the MEP designs During execution:Quality Assurance and Control- periodic site visits to monitor the progress of MEP installations and ensure compliance with the approved design plans and to verify that MEP systems are installed correctly and meet the design specifications.Testing and Commissioning- Participating in the final acceptance process for the hotel and handover procedures in cooperation with the companies performing the work. Deficiency Identification and ResolutionReview of the commissioning/acceptance reports and technical MEP-related documentation provided by the landlord, such as MEP design drawings, specifications, equipment manuals, and maintenance records. Verify the completeness and accuracy of the MEP documentation and assess its compliance with numa's standards and requirements. Identify any gaps or discrepancies in the documentation and coordinate with the LL to resolve themHandover Acceptance and Sign-off Prepare MEP handover documentation for the operation teams, including as-built drawings, equipment manuals, maintenance schedules, and warranties.Conduct training sessions for the operations team to familiarize them with the MEP systems, their operation, and maintenance requirements. Other: Review existing numa MEP standards, improve and/or create new ones Identifying and implementing workflow improvements in regards to MEPIdentifying time and cost saving opportunities for upcoming projects About youUniversity degree in engineeringKnowledge of all MEP disciplines Ideally with previous experience of working in the similar company, or for a developer Ability to build and maintain good relationships with external partiesExcellent stakeholder management and strong communication skillsWell-developed technical and creative skills, thinking outside conventional solutionsA good eye for detail Ability to work under pressure and on multiple projects at the same timeAdvanced knowledge of Google and Microsoft Suits, Smartsheet, Asana Planning and construction norms, regulations and contract law knowledge is a plusFluent in English is a requirement, German is preferred Fluent in other European languages is a plus ABOUT OUR OFFERJoin an agile work environment with flat hierarchies where your ideas make an impact from the very beginningBuild your own success story based on what you do well and how you want to growElevate your physical and mental wellness with our monthly benefit allowancesGet to know your internationally diverse team during our events and retreatsSpend a free night at your nearest numa stay upon starting and enjoy a 30% employee discount on personal stays in the coolest neighbourhoods in Europenuma values the diversity of the people it hires and serves. Diversity at our company means fostering a workplace in which individual differences are recognised, appreciated, respected and responded to in ways that fully develop and utilise each person's talents and strengths. We therefore welcome applications from people of all races, ethnicities, disability statuses, ages, religions, gender identities, and sexual orientations.For more information on the processing of your personal data, please see our Privacy Notice.Über das Unternehmen:numa

ABOUT NUMAHey! We're numa. We're a dynamic, diverse hospitality brand that's offering uniquely designed apartments for the modern traveler. We specialize in the beauty of convenience and the delight of a design, with a totally digital guest experience and properties designed with intention. Numa properties are located in the most exciting and vibrant neighbourhoods across Europe. We're not just disrupting the hospitality industry for our guests—behind the curtain, we're shaking up the way hotels operate. We've built a proprietary technology and data platform that makes running a hospitality operation more efficient than ever. We offer consistent quality and an unmatched guest experience. ABOUT THE ROLE:We are seeking a highly skilled, motivated, and impact-driven Due Diligence Specialist to join our team. As a key player, you will be entrusted with the responsibility of conducting numerous property inspections, delivering comprehensive reports crucial for informed decision-making. Executing both desktop and on-site evaluation of potential new properties, your tasks will include: Document review: Conduct comprehensive reviews of all documentation associated with new hotels Develop and maintain a checklist for tracking required documentation completion.Verify completeness and accuracy of documentation, ensuring compliance with company standards.Technical assessment and brand compliance:Evaluate physical condition of potential new properties and their alignment with numa brand standards, guidelines and requirements: design, operational, ICT, etc Evaluate the condition of existing systems: HVAC, electrical, plumbing, fire safety.Identify areas requiring refurbishment or improvements to meet numa requirements Identify deficiencies, repairs, upgrades Identify gaps or discrepancies between the site and the documentation Budget and timeline estimation:Develop detailed cost estimates for necessary renovations and operational upgrades to align with Numa standards Independently develop realistic timelines based on due diligence outcomesReporting:Compile and analyse data for detailed due diligence reports with photo documentationSummarise findings related to building status, brand alignment, budget estimates, and documentation complianceDevelop clear and concise recommendations based on due diligence findingsIndependently address concerns and red flagsCommunicate due diligence results and your recommendations effectively to internal and external stakeholdersContinuous Improvement:Participate in refining due diligence processes for enhanced efficiency Maintain close relationships with project managers to track project execution and incorporate learnings into the due diligence processEstablish a network of external technical consultants, advisors, and contractorsStay informed about industry best practices and independently incorporate relevant improvements ABOUT YOUUniversity degree in engineering, architecture, construction, real estate, business management, or similar Experience in due diligence processes, or project & construction management within the hospitality or real estate industry.Strong understanding of MEP systems and technical aspects of hotel operations.Ability to build and maintain good relationships with external partiesExcellent stakeholder management and strong communication skillsWell-developed technical and creative skills, thinking outside conventional solutionsA good eye for detail Excellent negotiation, communication, and presentation skills.Ability to work collaboratively with cross-functional teamsFluent in English is a requirement. Fluent in other European languages is a plus Flexibility to travel across Europe ABOUT OUR OFFERJoin an agile work environment with flat hierarchies where your ideas make an impact from the very beginningBuild your own success story based on what you do well and how you want to growElevate your physical and mental wellness with our monthly benefit allowancesGet to know your internationally diverse team during our events and retreatsSpend a free night at your nearest numa stay upon starting and enjoy a 30% employee discount on personal stays in the coolest neighbourhoods in Europenuma values the diversity of the people it hires and serves. Diversity at our company means fostering a workplace in which individual differences are recognised, appreciated, respected and responded to in ways that fully develop and utilise each person's talents and strengths. We therefore welcome applications from people of all races, ethnicities, disability statuses, ages, religions, gender identities, and sexual orientations.For more information on the processing of your personal data, please see our Privacy Notice.Über das Unternehmen:numa

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary: Responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure. Serves as the main point of contact at a country level for internal and external stakeholders. Position Responsibilities: Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s Assessment and set up the of vendors during study start up period (locally) Investigator Meeting participation and preparation Ensures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel Validation of study related materials (i.e. protocol, ICF, patient material) Responsible for preparing country specific documents (e.g. global country specific amendment) Prepares materials for Site Initiation Visits Responsible for verifying and confirming with local team eTMF completeness (Country and Site level) Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues. Coordination of database locks and query follow up. Ensures timelines are met. Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion. Lead study team meetings locally Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable) Management of Site relationships (includes CRO related issues) May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs) May perform site closure activities, including post-close out May act as point of contact for Sites May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances. Depending on the experience and previous knowledge of the specific candidate, the position may be adjusted to the Senior Level. Senior Level Expectations: Engage with Protocol Manager, line management and/or Head of Clinical Operations to assist in the resolution of complex issues both locally and/or globally Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned) Position Requirements: Degree Requirements: Bachelors or Masters degree required. Field of study within life sciences or equivalent Experience Requirements: Clinical Trial Manager: Minimum of 4 years' industry related experience Senior Clinical Trial Manager: At least 6 years of industry related experience Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives Key Competency Requirements: Thorough understanding of GCP, ICH Guidelines and Country regulatory environment In depth knowledge and understanding of clinical research processes, regulations and methodology Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management Demonstrated organizational and planning skills and independent decision-making ability Strong organization and time management skills and ability to effectively manage multiple competing priorities Ability of critical thinking and risk analysis. Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels Skilled in the use of technology Good verbal and written communication skills (both in English and local language). Software that must be used independently and without assistance (e.g., Microsoft Suite): Microsoft Suite Clinical Trial Management Systems (CTMS) Electronic Data Capture Systems (eDC) Electronic Trial Master File (eTMF) Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs. This fixed-term role is meant as maternity cover until 30.06.2025. #LI-Hybrid If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **********. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.Über das Unternehmen:0044 BMS GmbH&Co.KGaA Germany

Job Summary :Medpace is the leading CRO for Biotech companies and is continuing to add Clinical Trial Managers of different experience levels to join our Clinical Trial Management Group in the DACH region, specifically in Munich, Germany. Clinical Trial Managers with expertise in CNS and Neuroscience are welcome to continue to work in their area of expertise or to expand to a new therapeutic area. We provide remote flexibility after probation to the DACH region only with relevant experience. We offer a very competitive salary/bonus program, plus equity grants which have become very lucrative for our associates.Responsibilities :Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulationsServe as primary Sponsor contact for operational project-specific issues and study deliverablesMaintain in depth knowledge of protocol, therapeutic area, and indicationProvide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is providedReview and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicableDevelop operational project plansManage risk assessment and executionResponsible for management of study vendorManage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverablesQualifications :Bachelor’s degree in a health or life science-related field; Advanced degree in a health or life science-related field preferred;Experience in Phases 1-4; Phases 2-3 preferred;Minimum of 2 years of Clinical Trial Management experience, CRO experience preferred;5+ years of Project Manager/Clinical Trial Manager experience at a CRO required for a remote-based role;Management of overall project timeline;Bid defense experience preferred; andStrong leadership skills.Medpace Overview :Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.Why Medpace? :People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace PerksHybrid work-from-home options (dependent upon position and level)Competitive PTO packagesCompany-sponsored employee appreciation events Employee health and wellness initiativesFlexible work scheduleCompetitive compensation and benefits packageStructured career paths with opportunities for professional growthAwardsRecognized by Forbes as one of America's Best Mid-size Companies in 2021, 2022 and 2023Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect NextA Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets Über das Unternehmen:Medpace, Inc.

This position is responsible for organizing, planning and managing the personnel, systems and resources critical to the daily operation of the department(s). The Manager works cross functionally to ensure processes and procedures in place to align with regulatory requirements.Lead and manage employees to ensure that employees are fully trained, providing adequate leadership, mentoring, and support. Including active maintenance in keeping the site current with cGMP, including EU, FDA and other relevant foreign regulatory bodies.Ensuring that the Quality Management System is maintained in compliance with WuXi AppTec policies, ISO 17025, and any other applicable standards and regulations.Lead Quality Management Planning activities to ensure continued compliance, metrics, and other activities necessary for changes impacting the QMS.Providing leadership to the organization in QMS processes including Internal and External Audit Management, Management Review, Change Control, Document Control, Supplier Management, CAPA, NCE.Maintaining, enforcing, and managing a compliant and effective QMS, lean QMS structures and documents throughout.Lead/Support client, regulatory and accreditation audits and inspections; respond to inspection findings in a satisfactory and timely manner. Lead and/or participate on cross-functional teams and projects representing quality in positive and compliant manner. Work and interact in a collaborative manner at all levels of the organization.Support from the QA perspective validation / qualification activities for the facility, utilities and equipment. Responsible for hiring, transfer, promotion, discharge and salary changes of staff.Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.Ability to work in a team environment and independently as required.Contributes to the overall operations and to the achievement of departmental goals.Perform job specific tasks in compliance with applicable Regulations, International. Standards, and WuXi AppTec Policies and Standard Operating Procedures.Coordinate and support the alignment of US Quality Management systems.Responsible for the oversight of the Quality Assurance (QA) team.Participate/lead continuous improvement initiatives both within QA and cross functionally.Develop, implement and approve policies and procedures. Review, approve, and perform investigations. Provide guidance for non-compliance situations using creative problem-solving skills. Other duties as assigned.Experience / EducationPrevious role in QMS management in medical device, pharma or laboratory regulated quality management systems.Laboratory Management System knowledge would be a plus.Bachelor’s Degree or higher. Proficient knowledge of Quality Systems regulations and standards.Experience managing, hosting EU, FDA, Notified Body and/or customer audits.Minimum 5 years of experience.ISO 17025 and cGMP experience.Must have 3 or more years of experience managing personnel. Knowledge / Skills / Abilities:Ability to use judgment, clear problem-solving and decision-making skills.Ability to work under limited supervision and to handle complex problems.Excellent organizational and interpersonal skills. Ability to communicate effectively with all levels of the organization.Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices.Proficient in Oral & Written communication skills.Able to communicate (read, write, speak) in German and EnglishProficient in Microsoft (Excel, Word, Outlook).Physical Requirements:Must be able to work in an indoor office settingMust be able to wear appropriate PPEMust be able to work in environment with minimal noise levelsAbility to stand for long periods of timeAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

Location: Baden-Württemberg Germany - Site-basedSchedule: Freelance - 0.5 FTE   Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds…   The sponsor-dedicated division of ClinChoice, is searching for a Clinical Study Nurse to join one of our clients.   ClinChoice is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with their client counterparts.     Main Job Tasks and Responsibilities: Assists project teams with study-specific documentation as appropriate.Completion of Case Report Forms (CRFs/eCRFs) and Data Clarification Forms (DCFs).Tracking and Quality Control, maintaining drug accountability records, completion of site status reports.Ensures that review source documents e.g. laboratory reports are reviewed and signed by The Investigator.Understand ICH GCP, relevant regulations, and site SOPs.The maintenance of the study files and the databases for the project.Co-coordinates ordering/dispatch and tracking of trial materials.Assists project teams with trial progress tracking and updating distribution tasks by updating the Clinical Trial Management systems.Supports for tracking and safety reporting of study progress.Provides activity reports expenses and timesheets to the Company.Reporting of adverse events (AEs) serious adverse events (SAEs) to all relevant personnel parties.Entering data into the eCRF.Working with the Clinical Research Associate (CRA) to resolve queries.Adhering to the site and study-specific protocol training whilst undertaking visit duties.Maintaining standards of professional competence and current clinical practices under ICG_GCP, EU Clinical Trials Directive EU2001/20EC and German Regulatory Requirements.Completing study visits at the site in line with the study protocol requirements.Provision of excellent standards of service provision following study protocol training and country-specific requirement.Adhering to the Sponsor/Site training and study-specific protocol training, whilst undertaking visit duties.Ensures that all relevant information regarding subjects is recorded, reported and where necessary, acted upon the communicate any changes to the Investigator study team as appropriate.Working at site and Patient Services team and Country Lead to ensure that all aspects of service for assigned groups of subjects are met, through the adherence to study schedules, protocols, and local clinical practice regulations and requirements.Flexible approach to working hours to accommodate the dynamic nature of research visits. Education and Experience:Registered Nurse or Medical Assistant with at least 2 years of post-registration experiencePrevious experience as a Research Nurse or Medical Assistant including a recent (within the last 1 year) ICH-GCP update.Experience in neurology is desirable. Skills Requirement:Measurement of vital signs (i.e., blood pressure, pulse rate, BMI, etc.).Performing ECG.Drawing of blood.Performing the infusion including putting on the infusion tubes and clinical monitoring during/after infusion (following training).Ship blood/laboratory samples to the central lab (training and instructions will be provided).Check questionnaires.Report AEs/SAEs.Liaise with the study team.Enter visit data into eCRF.Database screening.Discuss study information with subjects to aid informed consent.Coordinates all participant visits including inviting study participants, coordinating the visits with the pharmacy, the neuroimaging unit, the local lab, and the home health.Coordinates accounting for travel expenses of study participantsAssists the Principal Investigator (PI) in determining subject eligibility.SAE reporting through safety gateway.Make eCRF entries/corrections/resolve DCFs…Selection and randomisation procedures using IRS.Communicate with IEC.Maintain documentation in the Investigator Site File.Infusion experience essential.Good phlebotomy skills.ECG recording.Managing infusion reactions.Demonstrated organisational skills.Proven flexibility and the ability to work under pressure.Good communication skills.Proficiency in German mandatory, English desirable.Proactive contribution towards the team by being a flexible team player.Ability to work effectively both in a team & independently in a fast-paced environment.Excellent understanding of the clinical processes.Good knowledge of clinical trials, including EU Clinical Trials Directives, Good Clinical Practice for Clinical Trials, and German regulations is desirable, training can be provided.Excellent computer skills required, MS Office proficiency at a minimum. The Application Process  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @  https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected] for more information.     Who will you be working for?     About ClinChoice       CROMSOURCE is now a ClinChoice Company. ClinChoice is a leading full-service CRO dedicated to offering high-quality one-stop service to the pharmaceutical, biotechnology, medical device and consumer products clients. Some of these services include Clinical Operations, Project Management, Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, and Pharmacovigilance. ClinCHoice has established major delivery centres across US, Canada, China, Europe, India, Japan and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence across Asia, North America, and Europe.        Our Company Ethos  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.     Keywords:  Study Nurse, Research Nurse, Trial Nurse, MS Office, German, Pharmaceutical, Pharma, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicatedSkills: Nurse, Registered Nurse, Clinical Research Organisation, clinical trials, CRO, MS Office, Pharma, PharmaceuticalLocation: GermanyShare: LinkedIn Facebook Twitter Email

Job ID: 92188 / Location: Trier / Start: as soon as possible JTI is a leading international tobacco and vaping company with operations in more than 130 countries and world-renowned brands such as Winston, Camel and American Spirit. Headquartered in Geneva, Switzerland, we employ over 48,000 people across the globe. In Germany, we are the largest employer in the tobacco industry. Around 1.800 employees at the Trier factory site and the Research & Development Center with Global functions ensure the high quality of our products with great commitment. Our factory in Trier exports all over the world, sets quality standards and makes it one of JTI's most important manufacturing sites. We are a member of the Japan Tobacco Group of Companies. For more information visit www.jti.com. In the R&D Packaging Department is an open position as Print Implementation Manager (m/f/d) to fill. Your Responsibilities:Responsible for project realization for all printed materials from tipping to shipping case from the project outset, covering the advisor/ expert role in discussions with all internal and external partners (Marketing & Sales, R&D Packaging, other JTI functions and external suppliers).Monitor and control usage of only qualified materials for JTI products. Onsite supervision of respective suppliers to ensure JTI quality standards. Coordinate qualification process with suppliers, NTM team, SRA and GSC for material tests.Preparation and maintenance of One Time Cost estimates for cross-regional/local packaging development initiatives. Request and check respective OTC quotations.Make sure that all internal systems will be used as required (CAPA, TPA, PLM) and support in developing new processes and systems as needed. Initiate and complete projects targeting process improvements and business efficiency enhancement in alignment with other Print & Design Implementation partners as well as the wider Packaging community. Your Profile:University or technical degree in Packaging TechnologyExcellent knowledge of prepress as well as the main printing and converting technologiesAt least 3 years of packaging experience within the FMCG industry (preferably cigarette packaging)Global and cross-cultural experience preferredExcellent technical skills in Printing and Converting of packaging materials, cigarette manufacturing experience preferredExcellent packaging material knowledge and Quality Assurance experienceComprehensive project management experience: planning to realizationExcellent English knowledge both written and spoken. Additional foreign language knowledge is advantageous, preferably GermanComputer literacy especially MS Office and PLM Systems. Adobe Acrobat/Illustrator knowledge is considered an assetFlexible and willing to travel Benefits:Good work-life balance (30 days annual leave, working hours: 37,5 hours per week)Attractive remuneration as well as 13th and 14th salaryVarious development opportunities, complemented by diverse training opportunitiesOpen and international working environment with more than 60 nationalities at Trier site Health managementCompany pension planCapital-forming benefits Canteen and free parking Diversity:JTI is committed to creating a diverse and inclusive work environment. We celebrate the differences that make us unique, and strongly believe in a world where you have the freedom to express yourself. Where you can be proud and confident of who you are. A world in which we all can develop to our full potential! Want to know more about Diversity and Inclusion at JTI?Please visit: https://www.jti.com/de/europe/germany/top-arbeitgeber Have we aroused your interest?Take your chance and join one of the "Top Employer 2024" in Germany. Apply directly with your complete application documents (CV, cover letter & certificates) stating your earliest possible starting date via our online system: www.jti.com/careers (Job ID 92188). Über das Unternehmen:JT International S.A.Branche:R&D, PLM, Marketing Manager, Quality Assurance, QA, Research, Management, Marketing, Quality, Technology

This position is responsible for organizing, planning and managing the personnel, systems and resources critical to the daily operation of the department(s). The Manager works cross functionally to ensure processes and procedures in place to align with regulatory requirements.Lead and manage employees to ensure that employees are fully trained, providing adequate leadership, mentoring, and support. Including active maintenance in keeping the site current with cGMP, including EU, FDA and other relevant foreign regulatory bodies.Ensuring that the Quality Management System is maintained in compliance with WuXi AppTec policies, ISO 17025, and any other applicable standards and regulations.Lead Quality Management Planning activities to ensure continued compliance, metrics, and other activities necessary for changes impacting the QMS.Providing leadership to the organization in QMS processes including Internal and External Audit Management, Management Review, Change Control, Document Control, Supplier Management, CAPA, NCE.Maintaining, enforcing, and managing a compliant and effective QMS, lean QMS structures and documents throughout.Lead/Support client, regulatory and accreditation audits and inspections; respond to inspection findings in a satisfactory and timely manner. Lead and/or participate on cross-functional teams and projects representing quality in positive and compliant manner. Work and interact in a collaborative manner at all levels of the organization.Support from the QA perspective validation / qualification activities for the facility, utilities and equipment. Responsible for hiring, transfer, promotion, discharge and salary changes of staff.Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.Ability to work in a team environment and independently as required.Contributes to the overall operations and to the achievement of departmental goals.Perform job specific tasks in compliance with applicable Regulations, International. Standards, and WuXi AppTec Policies and Standard Operating Procedures.Coordinate and support the alignment of US Quality Management systems.Responsible for the oversight of the Quality Assurance (QA) team.Participate/lead continuous improvement initiatives both within QA and cross functionally.Develop, implement and approve policies and procedures. Review, approve, and perform investigations. Provide guidance for non-compliance situations using creative problem-solving skills. Other duties as assigned.Experience / EducationPrevious role in QMS management in medical device, pharma or laboratory regulated quality management systems.Laboratory Management System knowledge would be a plus.Bachelor’s Degree or higher. Proficient knowledge of Quality Systems regulations and standards.Experience managing, hosting EU, FDA, Notified Body and/or customer audits.Minimum 5 years of experience.ISO 17025 and cGMP experience.Must have 3 or more years of experience managing personnel. Knowledge / Skills / Abilities:Ability to use judgment, clear problem-solving and decision-making skills.Ability to work under limited supervision and to handle complex problems.Excellent organizational and interpersonal skills. Ability to communicate effectively with all levels of the organization.Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices.Proficient in Oral & Written communication skills.Able to communicate (read, write, speak) in German and EnglishProficient in Microsoft (Excel, Word, Outlook).Physical Requirements:Must be able to work in an indoor office settingMust be able to wear appropriate PPEMust be able to work in environment with minimal noise levelsAbility to stand for long periods of timeAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

This position is responsible for organizing, planning and managing the personnel, systems and resources critical to the daily operation of the department(s). The Manager works cross functionally to ensure processes and procedures in place to align with regulatory requirements.Lead and manage employees to ensure that employees are fully trained, providing adequate leadership, mentoring, and support. Including active maintenance in keeping the site current with cGMP, including EU, FDA and other relevant foreign regulatory bodies.Ensuring that the Quality Management System is maintained in compliance with WuXi AppTec policies, ISO 17025, and any other applicable standards and regulations.Lead Quality Management Planning activities to ensure continued compliance, metrics, and other activities necessary for changes impacting the QMS.Providing leadership to the organization in QMS processes including Internal and External Audit Management, Management Review, Change Control, Document Control, Supplier Management, CAPA, NCE.Maintaining, enforcing, and managing a compliant and effective QMS, lean QMS structures and documents throughout.Lead/Support client, regulatory and accreditation audits and inspections; respond to inspection findings in a satisfactory and timely manner. Lead and/or participate on cross-functional teams and projects representing quality in positive and compliant manner. Work and interact in a collaborative manner at all levels of the organization.Support from the QA perspective validation / qualification activities for the facility, utilities and equipment. Responsible for hiring, transfer, promotion, discharge and salary changes of staff.Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.Ability to work in a team environment and independently as required.Contributes to the overall operations and to the achievement of departmental goals.Perform job specific tasks in compliance with applicable Regulations, International. Standards, and WuXi AppTec Policies and Standard Operating Procedures.Coordinate and support the alignment of US Quality Management systems.Responsible for the oversight of the Quality Assurance (QA) team.Participate/lead continuous improvement initiatives both within QA and cross functionally.Develop, implement and approve policies and procedures. Review, approve, and perform investigations. Provide guidance for non-compliance situations using creative problem-solving skills. Other duties as assigned.Experience / EducationPrevious role in QMS management in medical device, pharma or laboratory regulated quality management systems.Laboratory Management System knowledge would be a plus.Bachelor’s Degree or higher. Proficient knowledge of Quality Systems regulations and standards.Experience managing, hosting EU, FDA, Notified Body and/or customer audits.Minimum 5 years of experience.ISO 17025 and cGMP experience.Must have 3 or more years of experience managing personnel. Knowledge / Skills / Abilities:Ability to use judgment, clear problem-solving and decision-making skills.Ability to work under limited supervision and to handle complex problems.Excellent organizational and interpersonal skills. Ability to communicate effectively with all levels of the organization.Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices.Proficient in Oral & Written communication skills.Able to communicate (read, write, speak) in German and EnglishProficient in Microsoft (Excel, Word, Outlook).Physical Requirements:Must be able to work in an indoor office settingMust be able to wear appropriate PPEMust be able to work in environment with minimal noise levelsAbility to stand for long periods of timeAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

Clinical Research Associate / Klinischer Monitor / Site Manager (m/w/d) - homebased (Region Nord- oder Ostdeutschland) bei Alcedis GmbH | softgarden Clinical Research Associate / Klinischer Monitor / Site Manager (m/w/d) - homebased (Region Nord- oder Ostdeutschland) Vollzeit Gießen, Deutschland Remote Mit Berufserfahrung 07.02.24 Als Clinical Research Associate / Klinischer Monitor / Site Manager (m/w/d) - homebased (Region Nord- oder Ostdeutschland) - unterstützt du unsere Fachabteilung Clinical Operations beim Überwachen und Sicherstellen von Qualitätsmerkmalen in Gesundheitszentren vor Ort sowie bei der erfolgreichen Planung und Durchführung von Klinischen Arzneimittelprüfungen der Phasen I-IV, nicht-interventionellen Studien sowie Medizinprodukte-Studien. Du betreust eigenständig die entsprechende Region und wirst für eine optimale Einbindung in die Prozesse bei Alcedis 1-2 Tage im Quartal in Gießen (Hessen) eingesetzt. Was du bei uns tustOversight-Tätigkeiten/ Lead-Site-Management in nationalen und internationalen Projekten (z.B. Training des CRA-Teams, Review von Monitoring Reports, Koordination der Besuche und der regelmäßigen Kontakte zu den Zentren, Kontakt zum Sponsor bzgl. Monitoring/ Site Management) Klassische CRA-Tätigkeiten in Abhängigkeit der Projekte: Unterstützung bei der Organisation der Studie in den Prüfzentren und Betreuung der PrüfärzteVorbereitung, Durchführung und Nachbereitung von Initiierungs-, Monitor- und Abschlussbesuchen (On-site oder Remote/Online) inkl. BerichterstellungAbfrage des Studienstands in den Prüfzentren (nach vorgegebenem Leitfaden) sowie DokumentationValidierung der von den Prüfärzten erhobenen Studien-Daten (Quelldatenvergleich)Überprüfung der Prüfzentren auf Einhaltung der geltenden Richtlinien und GesetzeAbstimmung mit Datenmanager und ProjektleiterErstellung von Queries (Rückfragen) und Überwachung des Query-ProzessSchulung der Prüfärzte und Dokumentare auf EDC-SoftwareDurchführbarkeitsprüfung (Feasibility) für neue Projekte mit PrüfzentrenUnterstützung bei der Erstellung von Studienunterlagen inkl. Versand und TrackingVorbereitung von Unterlagen zur Einreichung bei Behörden und EthikkommissionenBegleitung von Audits/Inspektionen in den PrüfzentrenAdministrative Unterstützung der Teamleitung:Erstellung und Updates von SOPsEinarbeitung und Coaching von Junior-CRAsCo-Monitoring zur QualitätsüberprüfungMitwirkung bei der Überarbeitung des elektronischen Reporting-SystemsMonitoring-Konzepterstellung für Kunden auf Anfrage Wer du bistDu hast ein abgeschlossenes Studium aus dem Bereich der Naturwissenschaften oder Life Sciences, bzw. besitzt eine Study Nurse oder vergleichbare QualifikationBerufserfahrung (>2 Jahre) in der Durchführung GCP-konformer klinischer Studien innerhalb der Industrie (z.B. CRO, Pharma oder Biotech) ist verpflichtendDu arbeitest selbständig und vorausschauend bei Planung und UmsetzungDu besitzt eine hohe Sozialkompetenz und eine ausgeprägte Teamfähigkeit Du besitzt sehr gute Kommunikations- und OrganisationskompetenzenExzellente Deutschkenntnisse setzen wir vorausDeine Kenntnisse in Englisch (Wort und Schrift) sind sehr gutDu arbeitest gerne mit elektronischen Daten und Datenbanken und bringst gute Kenntnisse in den Office-Anwendungen mitDu besitzt Reisebereitschaft und Flexibilität Warum du dich für uns entscheidestWir leisten jeden Tag einen bedeutsamen Beitrag zum medizinischen Fortschritt - bei uns findest du eine Stelle, die nicht nur sinnstiftend ist, sondern auch deinem Purpose entspricht und ihn fördertDie fachliche Übereinstimmung ist wichtig, mindestens genauso viel zählen für uns aber auch eine angenehme Arbeitsatmosphäre, kollegialer Zusammenhalt und die Passung ins Team! Wir leben eine moderne und offene Unternehmenskultur mit flachen Hierarchien, ohne Dresscode und alle per Du – gerne auch schon im Bewerbungsverfahren Du findest in einem international erfolgreichen und stetig wachsenden Unternehmen ein zukunftsorientiertes und sicheres Arbeitsumfeld vor. Unser Fokus liegt auf langfristigen und vertrauensvollen MitarbeiterbeziehungenUnsere Vergütungsstruktur ist leistungsbezogen dynamisch gestaltet und bietet dir kontinuierliche EntwicklungsmöglichkeitenWir bieten 30 Urlaubstage bei einer 5-Tage-Woche, flexible Arbeitszeiten und ermöglichen dir im Rahmen einer homebased-Stelle die Option, von zuhause aus zu arbeitenNeben den kleinen Extras wie Obstkorb, Getränkeflatrate und Tischkicker bieten wir dir weitere attraktive Benefits, darunter Gesundheitsförderungsmaßnahmen, Job-Fahrrad, VWL-Zahlung, regelmäßige Firmenveranstaltungen und Teambuilding-Aktivitäten, wechselnde exklusive Mitarbeiter-Angebote und vieles mehr Deine BewerbungBereit für deinen neuen Job? Dann mache jetzt den nächsten Schritt - wir freuen uns über deine Bewerbung!Kontakt:Human Resources: Carolin Gerhard, Alcedis GmbH, Winchesterstr. 3, 35394 Gießen, 0641/ 94436-0 Standort Alcedis GmbH, Giessen