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Senior Clinical Research Associate
Allucent, Munich
Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.We are looking for a Senior Clinical Research Associate to join our team in GermanyThe Sr CRA will be responsible for the following tasks: Governs quality standards for trial monitoring activities. Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and Allucent SOPs for monitoring requirements. Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols. Tracks and supervises collection of ongoing study data for purpose of regular project status reporting. Collects and reviews regulatory documents as required. Prepares site visit reports and telephone contact reports. Maintains and updates CTMS in compliance with SOPs and study-specific directives. Acts as Document Owner for collected documents. May participate in the start-up process including preparing Informed Consent forms, developing study documents, EC / CA submissions, and / or site contract management Aims to pro-actively prevent and / or mitigate issues. Resolves site issues, including site recruitment challenges, and determines status for IP shipment. Acts as the main line of communication between the project team and the site staff. Works in collaboration with Allucent Centralized Monitoring Team to evaluate risk-based monitoring activities to facilitate oversight of the study conduct at the sites and prevent issues. Activities are related to but not limited to: Investigational Product supplies, non-IP study supplies, subject eligibility, protocol compliance, facilities, and PI oversight. Identifies potential logistical/practical problems and support Project team to create solutions / contingency plans, with timeframes for resolution. Ensures the continuous maintenance of the Trial Master File and Investigator Site File. Assists the Project Manager (PM) and Clinical Team Leader (CTL) with generation of study specific forms for completion by CRA and Investigators and follow up with the teams to ensure timely completion and submission. Works with Project Manager (PM); Clinical Team Leader (CTL), SSU (Study Start Up) team members or sponsor to ensure authorization of regulatory documents and site contracts. Attends Investigator Meetings (IM) to include organizing and presenting at investigator meetings. and study specific training meetings. May translate, coordinate translations or review completed translations of the essential documents as required. May participates in feasibility and/or site identification activities. Contacts local opinion leaders, medical consultants or specified investigators and identifies sites with the potential for participation. May follow feasibility procedures for documentation of feasibilities performed in collaboration with the Study Start Up Department. Where applicable, identifies the documentation required for review by Regulatory Authorities and Ethical Committees. May prepare Regulatory and Ethics Committee submissions working in conjunction with Study Start Up Department. Ensure written approvals are obtained and distributed appropriately prior to Site Initiation. Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required. May process interim and final payments to Investigators, including preliminary calculations, review and approval from Project Management, liaison with finance, logging trial expenditure, receipts, invoices, and income. Assists the Project Team with the day-to-day management of critical studies as required, including attendance at team meetings. Provides secondary in-house review of CRFs (if required). Support site staff in preparation for study related site audits and inspections. Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions. May be assigned other tasks / activities / responsibilities related to the study execution in the country. May support initiatives in the country, GCO, and / or CTO to contribute to improvements and quality. Must work both independently and in a team environment. Requirements At least three years clinical monitoring experience and/or relevant clinical trial experience. Relevant life science degree / health care / nursing background and/or related degree. Sound knowledge of medical terminology and clinical monitoring process. Strong communication in Local and English language in both written and verbal skills. Strong interpersonal and organizational skills. Ability to translate guidelines, rules and regulations in clear and usable recommendations Representative, outgoing and client focused Ability to work in a fast-paced challenging environment of a growing company In-depth therapeutic and protocol knowledge Ability to perform travel an average of 65%, depending on project needs. In-depth therapeutic and protocol knowledge as provided in previous, or company provided training. Attention to detail. Ability to work independently and to effectively prioritize tasks, establish, and maintain strong working relationships with co-workers, managers, investigators, site personnel and clients. Demonstrated ability to manage multiple projects. Administrative excellence Proficiency with various computer applications such as Word, Excel, and PowerPoint required Demonstrated ability to develop, organize and manage new skills and tasks and mentor colleagues. Ability to manage multiple projects Benefits Comprehensive benefits package Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for fully remote working or hybrid Working Model Leadership and mentoring opportunities Internal growth opportunities and career progression More task variety Financially rewarding internal Employee Referral Program Access to online soft-skills and technical training via GoodHabitz and internal platforms To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes#LI-BL1 Standort Allucent, Munich
Aktuar Non-Life / internationaler Versicherer (m/w/d)
InterJob® GmbH, Munich
Als internationales Personalberatungsnetzwerk sind wir auf die zukunftsgerichteten Belange der Finanz- und Versicherungswirtschaft spezialisiert.Wir verfügen über eine langjährig hohe Expertise in der Besetzung hochklassiger Funktionen im Umfeld spezialisierter Fragestellungen unserer Zeit.Ihre Entwicklung liegt uns am Herzen! Gemeinsam mit Ihnen wollen wir dazu beraten, welche Herausforderungen und Perspektiven Ihre erfolgreiche berufliche Vita voranbringen.Zur Unterstützung unseres international tätigen Mandanten, einer dynamischen, kapital- und wachstumsstarken Versicherungsgesellschaft suchen wir Sie im Rahmen eines sehr nachhaltigen Expansionsvorhabens alsAktuar Non-Life / internationaler Versicherer (m/w/d)AufgabenErstellung von Jahres- und Quartalsabschlüssen nach HGB Ermittlung der unterjährigen Erwartungen und Erstellung der strategischen PlanungAktive Mitwirkung bei der Solvabilitätsberechnung und dem quantitativen aufsichtsrechtlichen Reporting unter Solvency IIUnterstützung der versicherungsmathematischen Funktion bei der Validierung der versicherungstechnischen RückstellungenAnalyse und Bewertung von versicherungsmathematischen Fragestellungen sowie Erstellung von anlassbezogenen Auswertungen und regelmäßigen Statistiken für das interne und externe ReportingMentoring / Ausbildung neuer Kollegen und KolleginnenQualifikationErfolgreich abgeschlossenes Studium in den Bereichen Mathematik, Informatik, Data Science oder ähnlichem mit nachgewiesenem quantitativem Bezugbelastbare Kenntnisse im Bereich Solvency IIideal: eine bereits abgeschlossene oder laufende Ausbildung zum Aktuar (m/w/d) verhandlungssichere Sprachkenntnisse in Deutsch und EnglischInterdisziplinäre Denk- und Handlungsweise, ausgeprägte analytische und konzeptionelle Fähigkeiten sowie ein hohes Maß an Eigeninitiative und VerantwortungsbewusstseinBenefitsUmfangreiche Möglichkeiten zur persönlichen Weiterbildungeine auf Vertrauen, Förderung und konstruktivem Feedback basierende ArbeitsumgebungZusammenarbeit mit Menschen aus verschiedenen Ländern und Kulturen31 Tage Jahresurlaub Flexible Arbeitszeiten und die Möglichkeit, remote zu arbeitenumfangreiche betriebliche LeistungenJobtickets, Parkplätze, monatlicher FahrtkostenzuschussGesundheitsmanagementFür einen ersten vertraulichen Kontakt steht Ihnen Frau Saskia Behr (Tel +49 (0) 162 / 5869066) gerne zur Verfügung.Interessiert?Dann freuen wir uns auf Ihre aussagekräftigen Bewerbungsunterlagen unter Angabe Ihrer Einkommensvorstellung und des frühestmöglichen Eintrittstermins.Wir sind eine deutschlandweit tätige, auf Fach und - Führungskräfte spezialisierte Personalberatung im Executive Search Bereich mit weltweiten Dependancen. Standort InterJob GmbH, Munich
Program Manager - Product Life Cycle Management (PLM)
NewCore Business, Stockholm, Sweden
Job Description Do you want to leverage Product Lifecycle Management for Circular Transformation? Or to reduce environmental impact by using Product Lifecycle information? We strongly believe that Product Lifecycle Management is an enabler to reduce the environmental impact and retain material value within companies. Leveraging Product Lifecycle Management for Circular transformation. Therefore, we are looking for highly skilled PLM experts that have been part of implementing PLM solutions several times. The roleAs a program manager, your key responsibilities will be to lead and oversee a project or program within Product Lifecycle Management. You will be responsible for developing and managing business requirements, specifications, plans, timelines, resources, and risks. Furthermore, you will be the PLM Expert for the client on how the PLM Roadmap should be developed and implemented over time. This will include how Product Lifecycle Management can be used as a strategic enabler for our clients, especially for Circular Transformation. You will build and maintain relationships with client stakeholders. The right candidateWe think you have a deep understanding of Product Lifecycle Management with knowledge of industry standards, regulations, PLM platforms, and new technologies. You possess strong analytical skills and can identify areas for improvement and make recommendations to optimize clients' PLM processes. You contribute to the development of the PLM portfolio roadmap. You have a proven track record in leading several projects or programs that require a solid understanding of PLM. Additionally, you know how to develop Business Requirements, Concept Models, Information Models with a detailed understanding of MBSE, Mechanical, Hardware, Software, Manufacturing Engineering, Service, etc.
Capgemini Invent (Senior) Consultant Operational Risk
Capgemini Invent, Brussels, Belgium
Job Description Capgemini Invent is the Capgemini Group's global consulting unit for digital innovation, design and transformation. It enables CxOs to shape the future of their companies. More than 10,000 employees work for this at more than 36 locations and 37 creative studios worldwide. They combine strategy consulting, data science, product and experience design, brand management and technology expertise to develop new digital solutions, products, environments and business models for a sustainable future.As a (Senior) Consultant Operational Risk within Enterprise Transformation (“Finance Risk & Compliance”), you will help our clients in optimizing their Operational risk data infrastructure, defining and implementing their data management strategies, developing data-driven solutions and business models, as well as leveraging digital technologies to address ever increasing market and regulatory requirements. Role and Responsibilities As a (Senior) Consultant Operational Risk within Enterprise Transformation, the focus of your role will be enabling clients to leverage the power of data & analytics efficiently and successfully throughout their enterprise, in order to optimize their business processes, improve their operations and drive performance improvementWorking as a (Senior) Consultant, you’ll enjoy a variety of responsibilities including:• Developing Consulting Skills: Developing your communication, analytical and team skills; working effectively in a team with others; Learning and implementing the Capgemini Invent procedures and valuesDelivering for Clients: helping clients defining an Operational Risk data strategy; supporting innovative topics at the interface between business, risk, strategy, regulatory, data and IT; implementing a new operating model which supports innovation and acceleration through data & analytics; finding new ways of getting value from data; providing advice on what tools to use; how to manage data as an asset, how to set up new business models and capabilities. You’ll be empowered to prioritize your own workload in order to complete all jobs on time and to the high quality expected by the client.• Contributing to Capgemini Invent: as you develop your expertise, you’ll be encouraged to support business development activity and create engaging content to; take to market; inform your colleagues and promote working at Capgemini Invent.Qualifications and Education Requirements • 2-5 years’ experience in Operational Risk Management (Non-Financial Risk) within a renowned Management Consultancy Firm (preferred) and/or a Top Tier Banking InstitutionAn outstanding Master’s Degree in business engineering, applied economics, or similarPreferred Skills/Profiles/experiences • You have a strong knowledge of Operational Risk regulations and guidelines (i.e., BCBS: “Principles for the sound management of operational risk”)• You have a proven experience in Operational Risk Framework implementation and/or remediation (i.e., ORM policy, Risk Appetite Statements, RCSAs, loss database, KRIs, risk culture, reporting, etc.)• You have a good knowledge of Enterprise Risk Management• You have a strong understanding of banking processes, activities, and governance• You have a strong knowledge of capital charge methods, calculations & quantifications• You have a deep understanding of Internal Control frameworks (COSO/SOX)• You have experience in the implementation or enhancement of the three lines of defense model• You have a proven experience working with key “GRC” vendors, and/or knowledge of GRC magic quadrant, and/or in GRC tool roadmap implementation/ change management• You are data driven with competences or proven experience in projects automation• You are fascinated by the combination of Data’s technological understanding, strategic analysis and implementation work as well as the talent to think conceptually and analytically• You have a thorough understanding of Data Modelling, Data Governance, Data Quality and Machine Learning or AI concepts, and you have ideally a good knowledge of relevant software in the field of data management and business intelligence• You are certified ORC/FRM/PRM or willing to get a certification• You are an engaging storyteller with excellent written & oral communication skills• You are a proactive, team player with an entrepreneurial mindset and the drive to deliver high quality results.• You are fluent in English and at least French or Dutch.Additional Notes As a team, we value: • Engagement: We believe in providing a stimulating working environment where our consultants are empowered to share their values and are engaged in purposeful work• Specialism: We value sector expertise and ensure you’re aligned to your area of interest to maximize your sector knowledge• Empowerment: Our consultants are empowered to shape their own development plans, taking into account the needs of the business, together with their own interests and aspirations• A diverse and inclusive environment that embraces and values different points of view• Being part of a team: regular meetups, alumni events, and away days – connecting as a team, having fun and learning new skills• Your professional development: you will have the opportunity to receive best-in-class management consulting training from our Capgemini University in ParisCapgemini positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity. We are committed to hiring, developing, and retaining the best people to deliver innovative, world-class solutions for our clients. We foster an inclusive culture that enables everyone to achieve their full potential and enjoy a fulfilling career with us. Our comprehensive flexible benefits package and lifestyle policies enable our employees to balance their individual, family and work-life needs.
Quality Assurance Flanders - Life Sciences
Capgemini Engineering, Beerse, Belgium
Job Description About the positionThe Quality Assurance consultant holds a vital and challenging role in any life science company: ensuring the quality and safety of products going to patients through building a Quality Management System. Finding a way to balance quality with efficiency, keeping up with the ever-changing world of new products, techniques and requirements, and intensely collaborating with various other departments and stakeholders, ...We support our clients with our profound knowledge and expertise in all quality subjects. Whether they are building a new production plant, developing new analytical methods, implementing a new quality regulation, or simply trying to solve issues and close gaps, we are there to ensure their success. Are you up for this challenge? Depending on your specific project, your role will be toBuild the Quality Management System (QMS)Discover, track and discuss problems, non-conformities and deviations within a production plant, a laboratory, a warehouse & distribution center, ...Launch, execute and document quality issues & investigationsPerform root cause analyses to determine the true source of any issueDevise CAPAs (corrective & preventive actions) to resolve the problems and prevent it from happening againCreate or improve operating procedures, work instructions, templates, quality systems, etc... To keep up with an ever-changing world.Own change controls , assessing the impact and ensuring the quality and compliance of the business throughout any changeGive trainings to operators, lab technicians, engineers, ... in your new proceduresPlan, organize and execute the review and approval of qualification reports, test protocols, validation documents, ... Together with the engineers and subject matter expertsManage or coordinate projects to implement changes within your QMSQualify, approve, monitor and periodically re-evaluate suppliersPrepare, assist and even lead internal and external auditsCollect, analyze and presentquality metrics and KPIs to determine the most strategic way forwardYour profileA University Master's degree in a relevant scientific subject (bioscience, chemistry, pharmacy, healthcare, ...)A high professional level of English and fluent in Dutch At least a first thorough QA experience in GMP environment. Depending our your seniority, the task will be adaptedMobility towards at least one of our major clients located in Puurs, Beerse, Geel, Ghent, ...A consultancy mindset :Ready to jump in a new project, quickly gain the skills and knowledge needed to support your client, and seeing any challenge as an opportunity to (im)prove yourself.Socially fluent: build your professional network at both the client and Capgemini.Business acumen: Analyze and evaluate the client's organization to identify their challenges and needs, so we can offer them solutionsKnowledge capitalization: capture and share your knowledge and expertise with other consultants and make use of Capgemini's tools to boost yourselfWhat we offerWithin Capgemini, you will be part of a global company with endless opportunities, yet we offer a very individual and personal approach and follow-up of each consultant through small teams, led by dedicated Team Managers here in Belgium.Challenging and meaningful projects, attuned to your own skills and interests, at the most renowned pharmaceutical companies in the world.The entire knowledgebase and expertise of Capgemini to support you on your projects and develop your own skills through live trainings, e-learning platforms, knowledge sharing workshops, coaching by senior consultants, etc...An extensive and transparent career framework allowing you to plan and follow your own career path: whether you want to grow into a senior consultant/expert/architect or move into Team/Account/Solution/Project Management, we are here to help you achieve your maximum potential.A highly competitive and broad salary package, including company car with fuel/energy card.
Risk Manager (m/w/d) Germany
Northvolt, Heide, Germany
Job Description With Germany being the core of European automotive manufacturing, its only natural it should also be a pioneer in scaling up battery cell manufacturing. At Northvolt we are excited to make this happen, and we have recently announced that Heide, Schleswig-Holstein, will be the location of our German Battery Gigafactory. The factory will be built in multiple phases over 5+ years and the factory represent a multi-billion Euro investment project. To enable this project we are now looking for a dedicated and driven Risk Manager to join us in our mission to contribute to a greener future.About the jobAs Risk Manager for the local Factory Program team you will play a key role in the effective anticipation of risk and opportunities across all aspects of our programs and projects. You will serve as the subject matter expert on risk management and work closely with cross-functional teams to audit, modify, and oversee the use of our risk management process. Your responsibilities will encompass tracking and progressing the risk process by the risk owners, ensuring timely follow up of risk mitigations, supporting the ongoing update and management of the risk profile and seeking improvement for the current processes. About the teamYou will be part of the Northvolt project team of about 40 employees that will have the overall responsibility of this mega project based in Heide Germany. Key responsibilities include but are not limited to:Driving risk-based thinking in the Factory program and its projects, supporting and administering the Risk Management Process as well as coordinating the systematic management of risks and opportunities through the risk ownersFacilitating monthly risk reviews with the delivery teams and preparing risk and mitigation inputs and eventually driving the Quantitative Risk Analysis reviews for the program team.Developing the digitalization for risk and change managementManaging stakeholders in a cross-team environment and produce status report to the management teamSuccess factors for this position:In addition to these requirements, a Change Manager in the Construction Industry must have strong attention to detail, be able to work under pressure, and have a strong commitment to ethical conduct and compliance with legal and regulatory requirements. They should possess excellent leadership, organizational and time-management skills and be able to lead and work effectively and efficiently in a team environment. They should be able to work collaboratively with the construction team to ensure project success.The person we are looking for is driven, caring, and structured. You thrive by leading others and working towards common goals. You are used to a high-paced work environment and got good time management skills. Qualities that we cherish are flexibility, a sense of quality, friendliness, motivation to take on new challenges, grit, and a sense of humour. Northvolt is an equal opportunity employer. We're a diverse group of individuals, united by a common mission, who recognise that while our actions as individuals have a role to play in driving Northvolt towards its goals, we always seek to move forward as a team. We offer you an open and welcoming atmosphere where we win as a team – and fail as a team. Northvolt is growing at the speed of light and we are a strong believer in internal career development. Apply with CV in English or your complete LinkedIn profile. Full time employment, fixed salary. Planned starting date is asap.
Senior Technical Cyber Security Consultant
WithSecure, Copenhagen, Rued Langgaards Vej København, Denmark
Job Description WithSecure delivers research-led cyber security to defend organizations, society and people from real-world attacks and build resilience into their approach. Our people are a mix of technical and creative experts – diverse, talented, and passionate people – working tirelessly to help us advance the industry with new ways of thinking. They lead their own development, in and out of the office. They call the shots when it comes to building a place to call home in our organization. Our mission is to assist our clients in being more resilient tomorrow than what they are today. In order to achieve that mission, we need people that love breaking (into) stuff or investigate what happened during a cyber incident. In our Consulting unit you will be doing that and not only, as a Senior Technical Cyber Security Consultant. You will use your knowledge and experience in partnering with our clients to continuously enhance their cyber resilience. We are currently looking for experienced people to join our offensive team in Copenhagen, as technical Senior Cyber Security Consultants. Key responsibilities Your primary responsibility will be to conduct professional security assessments for our clients across all our verticals (finance, gambling, critical infrastructure, world-leading brands), as well as consulting and advisory services, resulting in world-class assessment reports and presentations The bulk of your work will consist of a mix of security assessments, web applications, mobile applications, infrastructure, and server deployments. Based on interest and skillset, code review, cloud assessments (across multiple providers), SOC assessments, purple team exercises, red team engagements and hardware hacking is also on the table Support and mentor junior colleagues, lead projects, and generally contribute to the success of the team as a whole What are we looking for An experienced and creative security professional who is not limited to following checklists or pre-defined test cases. Our clients' solutions and requirements are continuously evolving, and your approach to testing needs to do the same We are looking for someone with hands-on experience with discovering and exploiting vulnerabilities Someone with experience beyond security products, IT procurement, and installing or deploying security software or appliances. We BREAK processes, products, and software. We are technology agnostic, and we work with what makes sense for the given task We are looking for a candidate capable of going beyond the OWASP Top 10 and scanning for low-hanging fruits. We expect you to be able to identify exotic, obscure, and sometimes down-right bizarre configurations and deviations from best practices Here is what we Do: Security assessments, pentesting, hacking, cracking, reverse engineering, etc. It has many names, but the point is that we attempt to break the security models, products, applications, code and features employed by our clients to help improve the overall security posture of their business, before the threat actor does Automated and manual vulnerability discovery, enumeration, identification, and exploitation. We expect you to have experience with all of these, and know when to do one and not the other Web application, mobile application, web services and API security assessments. We do these based both on automated and manual source code review, runtime testing and high-level architecture reviews, utilizing our many years of experience with offensive tooling and understanding of application vulnerabilities Business impact analysis, contextualizing vulnerabilities and articulating risk. Because a cool hack, technical writeup, or concise CVSS score, means very little to actual businesses, unless you can explain exactly how a vulnerability or weakness could end up hurting the client Executive writing, high-level summaries of complex technical content for non-technical senior managers, as well as nitty gritty detailed technical writeups, steps to reproduce, and actionable recommendations aimed at developers, system administrators and solution owners Requirements: A clean criminal record. You must be able to obtain a security clearance, and stand up to a standard background check You have a core understanding of computing and information systems, network technology, trusted computing principles, secure development practices and modern applications across multiple platforms Excellent English skills, both orally and in writing (any other languages are simply a bonus) Consulting experience within the cyber security field You are self-motivated, a problem-solver and have a life-long learning mindset that drives you to continuously learn and apply that knowledge in your partnership with clients You are structured in your approach and have the ability to support your peers in a structured and reproducible manner, to help uplift the efforts of everyone around you Great communication skills and the ability to present technical jargon in an understandable way You are not fazed by stressful situations, and are able to keep your head cool when our clients might be stressed and lose their cool Bonus points Information security certifications such as OSCP, OSCE, GPEN, GWAP, CEH, CRTP, CISSP or similar. Technical certifications relating to security testing are not a requirement, but for sure a bonus. If you don't have any, don't worry, we value experience and skillset way above pieces of paper A degree in Computer Science or equivalent experience or training You run your own lab environment, experiment with existing tools, develop your own tool, contribute to FOSS projects, participate in industry and community events such as conferences, hackerspaces or CTFsWhat will you get from us Expected salary in the range of 40k-60k DKK, depending on qualifications and experience Benefits including Extensive health insurance Company supported sport activities and other wellbeing support Paid phone and home Internet Paid parental leave A great lunch arrangement, that serves tasty and varied food catering to most diets A bright and spacious office, with excellent chairs, monitors, and peripherals An opportunity to work with some of the best technical security people in Europe with a wide variety of passions and skills A chance to do what you are passionate about and get paid for it An opportunity to work with some of the most demanding and interesting clients in the world