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Clinical Research Associate
CTi Clinical Trials & Consulting Service GmbH, Ulm
Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts.As a Clinical Research Associate (level depends on experience) you will be responsible for the successful conduct of clinical trials and serve as main contact for the investigative site by representing CTI in a professional manner.TasksWhat You’ll DoServe as main CTI contact for assigned study sitesConduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCPAssist with or oversee study start-up activities, including feasibility, pre-study activities and site selectionCollect, review and track essential/regulatory documentsParticipate in and complete all general and study specific training as requiredParticipate in investigator, client and project team meetings; may include presentationsCreate and implement subject enrollment strategies for assigned study sitesEnsure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materialsPerform site management activities and provide ongoing updates of site status to Clinical Project ManagerConduct remote monitoring and complete related activities in accordance with study specific Monitoring PlanUtilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IPAssist with project-specific activities as member of Project TeamRequirementsWhat You Bringminimum 2-3 years clinical research experience as a CRA or related profession in Germany - without the experience an applications doesn't make any senseLife science backgroundExcellent knowledge in ICH-GCP and regulatory requirementExperience in Transplant and AKI or oncologyFluent in spoken and written language in German and in EnglishBenefitsWhy CTI?At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.For that reason, we treat our team members with the respect they deserve, and our numbers show it:We support career progression – We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forwardWe value education and training – We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training departmentWe value our people - We guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time and a hybrid work from home scheduleOur culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industryWe think globally and act locally – With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROsOur work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to marketAfter an appropriate period of training, we offer you an unlimited, varied and attractive job in an international company.Are you interested? Then we look forward to your electronic application, with a tabular CV in English, as well as information about your earliest possible starting date and your salary expectation!CTI Clinical Trial and Consulting Services Europe GmbHFrau Samy WeiseSchillerstrasse 1/15 | 89077 Ulm, GermanyFrom a small team in an old carriage house to associates in more than 60 countries across the world. Standort CTi Clinical Trials & Consulting Service GmbH, Ulm
Clinical Business Development Manager (100% Remote)
UNOQUIP, Stuttgart
About the jobUNOQUIP was founded on a simple idea: Expert Solutions to improve patient care. With experienced international partners, we are marketing and selling medical devices in the field of fluid management, respiratory care, airway management and nursing care.Are you ready to take on this mission? Reporting to the Commercial Head of DACH, you’ll take care of UNOQUIP's Clinical Sales and Business Development in Germany. The purpose of this position is to deliver real clinical value to health care professionals and business partners – go beyond product to improve patient outcomes.1. Who are we?Founded in October 2022, UNOQUIP is a fast-growing global marketer of high-quality single-use medical devices. We are dedicated to equipping healthcare professionals with solutions to provide optimal patient care in acute care settings.We are an international, experienced, and highly committed team with a passion for what we do. UNOQUIP strives to be recognized as experts in solutions for single-use medical devices. We work closely with our customers to deliver superior solutions, with exceptional service and with the clear purpose of improving patient outcomes.UNOQUIP is headquartered in Schaffhausen, Switzerland and has offices and direct presence in Spain, Denmark, Sweden, Norway, Finland, U.K. and Australia. UNOQUIP also collaborates closely with global distribution partners, all of whom have extensive medical device expertise and share our commitment to providing solutions that meet the needs of the healthcare sector. Distribution to our customers is organized from four distribution centers in Belgium, the UK, and Australia.What We Value:· Trust: We build relationships based on trust, internally and with our valued business partners.· Passion: We seek individuals who are passionate about making a difference in the healthcare industry.· Positive Mindset: A positive outlook is the key to finding the right solutions and overcoming challenges.2. What will you work on? You will be responsible for a wide range of responsibilities and tasks related to the direct clinical sales of UNOQUIP products in Germany, as well as liaising with our distribution partners in Austria and Switzerland. A key element of the role will be to provide clinical support to our business and Group Purchasing Organisation (GPO, Einkaufsgemeinschaften) strategy.You will work in an operational role and be responsible for building strong and sustainable relationships with healthcare professionals and decision makers, demonstrating an outstanding level of accountability with focus on customer needs and UNOQUIP's business objectives. This is an exciting opportunity to join a young organisation and make a significant and defining impact on our regional presence in the DACH region. 3. Your areas of knowledge and expertise (that matter most for this role):You will be responsible for the following areas:Maximising the clinical awareness for our products and their benefits, resulting in increased usage of our products in the region.Developing business concepts, total cost of care / budget impact models and perform other activities in line with our strategies, creating value for the customers and increasing UNOQUIPs footprint and sales.Adding the clinical angle to drive product- price and mix favourable for customers and UNOQUIP.Providing clinical training support and mentor your colleagues with continued education.Building and executing regional competitive growth strategies on focus products.Partnering with local teams and regional organisations (such as nursing associations) to conduct clinical events.Driving clinical projects from start to completion while utilizing project management skills to reach strategic objectives.Creating and developing innovative ways to reach and educate customers.Maintaining an understanding of current clinical regulations and common industry practices.Identifying and driving new business opportunities and ensure commercial clinical execution versus strategy.In this multifaceted, important position you will report directly to the commercial head of DACH while also have your own territory.4. You have / you are:Bachelor’s degree in Life Science or Business-related subjects or other relevant education.A strong clinical understanding, preferably a clinical nursing background in acute care.Strong, empathic presentation skills including presentations in front of clinical stakeholders.A talent to interact with healthcare professionals and operating in complex clinical environments like intensive care units.Proven ability to work within a team with a can-do attitude, being open for new experiences and changes.Good selling skills, while not necessarily being a sales expert.A talent for identifying trends and future requirements and being able to share and distribute the knowledge in a wider organisation.Experience of working in the Medical Device Industry will be an advantage.Through effective decision-making, planning, and implementation, deliver superior business results within tight deadlines.Analytical & IT skills, including ability to efficiently work with excel calculations and databases.Confident personality with an engaging positive mindset and attention to detail.Work with minimal supervision, good initiative, and follow-up, focus on details, while understanding how work fits into the larger picture.100% proficient in your local language (German), written and spoken, and in English.Other requirements:Ability to travel 50% of the working time.References from at least 2 senior managers and from 2 reputable customers.Desired:Experience in working in international organisations and/or project groups.Preferred experience in using MS Dynamics 365.5. What can we offer you?Engage in building an international medical device start-up with a strong patient focus and international colleagues.Be part of an energetic, collaborative, and positive culture.Basic and ongoing training in our product range and market trends, to enable competent exchanges with suppliers and customers.Become involved in a very meaningful project in the healthcare industry.Company car.Up to 28 days of vacation.Ability to work 100% remotely.6. Interested?Complete the LinkedIn application.We aim to give you an initial response within 2 weeks. Next steps are communicated in the phone call with recruiters.As a candidate, you consent to UNOQUIP storing your CV and application for the purpose of recruiting for the specific positions advertised here. We will keep the data for a maximum of 6 months, during which time you can also ask us to delete your data by writing us through Linkedin with subject “GDPR - Your full Name”. Standort UNOQUIP, Stuttgart
Clinical Study Nurse
Pharmiweb, Tübingen
Clinical Study Nurse at ClinChoice (View all jobs) Tübingen, Germany Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds.... ClinChoice is searching for a Clinical Study Nurse to join one of our clients, where you will work on-site at a hospital in Tübingen, initially 0.5 FTE for a 12 month contract. ClinChoice is a global full-service 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 the client counter-parts. Main Job Tasks and Responsibilities: Measure vital signs (i.e. blood pressure, pulse rate, BMI, etc.), perform ECG’s, draw blood and perform infusions including putting infusion tubes and clinical monitoring during/after the infusion. Ship blood and laboratory samples to the central labs. Check questionnaires, perform database screening and discuss study information with subjects to aid with informed consent. Support the Principal Investigator with subject eligibility. Maintain Investigator Site File. Assist project teams with study-specific documentation as appropriate. Complete Case Report Forms (CRFs/eCRFs) and Data Clarification Forms (DCFs). Track, quality check and maintain drug accountability records. Ensure completion of site status reports. Ensure source documents (e.g. laboratory reports) are reviewed and signed by The Investigator. Maintain study files and the databases for assigned projects. Co-coordinate ordering/dispatch and track trial materials. Assist with trial progress tracking and update distribution tasks by updating the Clinical Trial Management systems. Support with tracking and safety reporting of study progress. Provide activity reports, expenses and timesheets as required. Report adverse events (AEs) and serious adverse events (SAEs) to all relevant personnel parties. Enter data into the eCRF. Work with the Clinical Research Associate (CRA) to resolve queries. Adhere to the site and study-specific protocol training whilst undertaking visit duties. Maintain standards of professional competence and current clinical practices under ICG-GCP, EU Clinical Trials Directive EU2001/20EC and German Regulatory Requirements. Complete study visits at the site, in line with the study protocol requirements. Ensure all relevant information regarding subjects is recorded, reported and where necessary, acted upon the communicate any changes to the Investigator study team as appropriate. Work at site and Patient Services team 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 experience. Previous 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 Requirements: 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 ProcessOnce you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for 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. Who will you be working for? About ClinChoiceClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company EthosOur mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice 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 to 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. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Study Nurse, Research Nurse, Trial Nurse, Registered Nurse, Clinical Trials, Clinical Research, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated #LI-DNP
Clinical Study Nurse
Pharmiweb, Stuttgart
Clinical Study Nurse at ClinChoice (View all jobs) Tübingen, Germany Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds.... ClinChoice is searching for a Clinical Study Nurse to join one of our clients, where you will work on-site at a hospital in Tübingen, initially 0.5 FTE for a 12 month contract. ClinChoice is a global full-service 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 the client counter-parts. Main Job Tasks and Responsibilities: Measure vital signs (i.e. blood pressure, pulse rate, BMI, etc.), perform ECG’s, draw blood and perform infusions including putting infusion tubes and clinical monitoring during/after the infusion. Ship blood and laboratory samples to the central labs. Check questionnaires, perform database screening and discuss study information with subjects to aid with informed consent. Support the Principal Investigator with subject eligibility. Maintain Investigator Site File. Assist project teams with study-specific documentation as appropriate. Complete Case Report Forms (CRFs/eCRFs) and Data Clarification Forms (DCFs). Track, quality check and maintain drug accountability records. Ensure completion of site status reports. Ensure source documents (e.g. laboratory reports) are reviewed and signed by The Investigator. Maintain study files and the databases for assigned projects. Co-coordinate ordering/dispatch and track trial materials. Assist with trial progress tracking and update distribution tasks by updating the Clinical Trial Management systems. Support with tracking and safety reporting of study progress. Provide activity reports, expenses and timesheets as required. Report adverse events (AEs) and serious adverse events (SAEs) to all relevant personnel parties. Enter data into the eCRF. Work with the Clinical Research Associate (CRA) to resolve queries. Adhere to the site and study-specific protocol training whilst undertaking visit duties. Maintain standards of professional competence and current clinical practices under ICG-GCP, EU Clinical Trials Directive EU2001/20EC and German Regulatory Requirements. Complete study visits at the site, in line with the study protocol requirements. Ensure all relevant information regarding subjects is recorded, reported and where necessary, acted upon the communicate any changes to the Investigator study team as appropriate. Work at site and Patient Services team 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 experience. Previous 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 Requirements: 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 ProcessOnce you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for 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. Who will you be working for? About ClinChoiceClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company EthosOur mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice 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 to 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. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Study Nurse, Research Nurse, Trial Nurse, Registered Nurse, Clinical Trials, Clinical Research, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated #LI-DNP