Clinical Research Associate 2

vor 3 Wochen

Lausanne, Schweiz Veranex, Inc. Vollzeit

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.

**About This Role**:
Veranex has an exciting opportunity to join our team as a Clinical Research Associate. You will be part of a team working to improve lives globally through medical technology innovation. The Clinical Research Associate will be responsible for organizing and overseeing clinical studies and ensuring the studies are conducted, recorded, and reported in accordance with all applicable regulatory requirements, good clinical practice (GCP), the study protocol and standard operating procedures (SOPs).

**What You Will Do**:

- Acts as project resource to clinical site, sponsor, and internal stakeholders regarding the product under investigation and the clinical study conduct
- Supports study activities to meet protocol and client objectives, maintaining regulatory compliance and professional integrity for clinical studies
- Contributes to the development of study documentation, e.g., protocol, informed consent, case report form (CRF) and study specific plans (monitoring plans, data management plans) as well as annual progress reports (APRs) and the clinical study report (CSR).
- Manages and maintains the documentation of all clinical study activities in the study Trial Master File
- Confirms data quality/integrity by participating in site qualification and monitoring visits (site initiation, monitoring, and site close-out), reviewing adverse events and device deficiencies, reviewing data trending/metrics, reviewing audit reports, and implementing corrective actions as necessary
- Establishes regular lines of communication and assists with administration of protocol and related study training to assigned sites

We currently offer this position in one of our following European offices: Brussels - Belgium, Paris - France, Lausanne/Olten - Switzerland, Berlin/München - Germany, Barcelona - Spain, Stockholm/Gothenburg - Sweden, London - UK.

**Qualifications**:
**Required skills**:

- Bachelors’ degree in life sciences or related discipline
- 2-4 years’ relevant work experience in the medical device field
- Strong knowledge of Good Clinical Practice (ISO 14155) and/or Good Study Practice (ISO 20916)
- Good knowledge of the European regulations MDR (EU 2017/745) and/or IVDR (EU 2017/746)
- Good written and oral communication skills in English
- Good organizational and time-management skills
- Excellent attention to detail
- Ability to multitask and prioritize work
- Good ability to work in cross-functional teams
- Able to travel (25-50%)

**Preferred**:

- Good knowledge in risk assessment
- Good knowledge in statistics
- Other languages such as French, German and Italian a plus
- Takes a proactive approach to work
- Good knowledge in cardiology
- IVD experience

  • Associate Scientific Director, Clinical

    Vor 7 Tagen

    Lausanne, Schweiz Merck KGaA Darmstadt Germany Vollzeit

    Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...

  • Tenure Track Assistant Professor Towards Associate

    vor 4 Wochen

    Lausanne, Schweiz Springer Nature Vollzeit

    **Tenure Track Assistant Professor towards Associate Professor in the field of biomedical sciences**: - Employer- University of Lausanne (UNIL)- Location- Lausanne, Canton of Vaud (CH)- Salary- Closing date- 23 Apr 2024- Discipline Biomedicine, Life Science Job Type Professor Employment - Hours Full time Duration Fixed term Qualification PhD ...

  • P2305 - Clinical Scientist

    vor 4 Wochen

    Lausanne, Schweiz Debiopharm Vollzeit

    Description Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to...

  • Postdoctoral Researcher

    Vor 4 Tagen

    Lausanne, Schweiz Université de Lausanne Vollzeit

    **Introduction**: The University of Lausanne (UNIL) promotes learning, research and living and hosts 14'100 students and nearly 3'800 collaborators, professors, and researchers. Ideally situated along the lake of Geneva, near Lausanne's city center, its campus brings together over 120 nationalities. **Presentation**: **Job information**: Expected start date...

  • Medical Director in Clinical Development

    vor 4 Wochen

    Lausanne, Schweiz Debiopharm Vollzeit

    Description Debiopharm is privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery...

  • P2406 - Clinical Trial Lead

    vor 3 Wochen

    Lausanne, Schweiz Debiopharm Vollzeit

    Debiopharm is privately-owned Swiss biopharmaceutical company commitmented to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery products and...

  • Global Clinical Development Lead

    vor 3 Wochen

    Lausanne, Waadt, Schweiz Nestlé Suisse S.A. Vollzeit

    Global Clinical Development Lead - Drug Develop Rare Diseases / IEMGlobal Clinical Development Lead - Drug Develop Rare Diseases / IEMPosition Snapshot Location: Nestlé Health Science Lausanne, Switzerland Company: Nestlé Health Science Act. Rate: Full-Time Act. Rate 100% Type of contract: Permanent contract What we offer at Nestlé Flexible work...

  • Medical Director in Clinical Development

    vor 3 Wochen

    Lausanne, Schweiz Debiopharm Vollzeit

    Debiopharm is privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery products and...

  • P2306 - Clinical Operations Transparency Lead

    Vor 4 Tagen

    Lausanne, Schweiz Debiopharm Vollzeit

    **_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in _oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop...

  • P2306 - Clinical Operations Transparency Lead

    Vor 4 Tagen

    Lausanne, Schweiz Debiopharm Vollzeit

    Description Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to...

  • Pre-clinical Project Manager

    Vor 7 Tagen

    Lausanne, Schweiz HAYA Therapeutics SA Vollzeit

    **The Company** HAYA Therapeutics SA is a precision therapeutics company that discovers and develops innovative tissue ‍ **About the job** **Primary responsibilities** - Organizing, overseeing and managing non-clinical studies with Contract Research Organizations (research and GLP) to support the product development - Presentation of pre-clinical...

  • Controlling Associate

    vor 1 Woche

    Lausanne, Schweiz Debiopharm Vollzeit

    Description Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to...

  • Tenure-track Assistant Professor Toward Associate

    vor 1 Woche

    Lausanne, Schweiz Centre hospitalier universitaire vaudois Vollzeit

    **Contexte**: The appointee will develop competitive research programs in data science to study and understand a wide range of biological and clinical questions, including but not limited to single-cell analyses, systems biology, spatial transcriptomics, microbiome analysis, epigenomics, and visualization of complex data**.** Applicants must have a strong...

  • Pre-clinical Project Manager

    vor 4 Wochen

    Lausanne, Schweiz HAYA Therapeutics SA Vollzeit

    **Location**: Lausanne, Switzerland **Conditions of Employment**: Proof of Eligibility to work in Switzerland (Swiss work permit or Swiss / European citizenship or graduated within the last 6 months from a Swiss academic institution) The position comes with an excellent compensation and benefits package. ‍**About the job** **Primary...

  • Global Clinical Development Lead

    vor 4 Wochen

    Lausanne, Schweiz Nestle Operational Services Worldwide SA Vollzeit

    **Position Snapshot** Location: Nestlé Health Science Lausanne, Switzerland Company: Nestlé Health Science Act. Rate: Full-Time Act. Rate 100% Type of contract: Permanent contract **What we offer at Nestlé** Flexible work policies in terms of core hours and working from home. Please talk to us during the recruitment process about what flexibility could...

  • Postdoctoral Researcher Snsf in Family Psychology

    vor 4 Wochen

    Lausanne, Schweiz Université de Lausanne Vollzeit

    **Introduction**: UNIL is a leading international teaching and research institution, with over 5,000 employees and 17,000 students split between its Dorigny campus, CHUV and Epalinges. As an employer, UNIL encourages excellence, individual recognition and responsibility. **Presentation**: To complete the team, the Institute of Psychology of the Faculty of...

  • Associate Specialist Microbial Metabolites

    vor 3 Wochen

    Lausanne, Schweiz Nestlé Vollzeit

    Position Summary Nestlé Research is based in Lausanne, Switzerland, employs approximately 1000 people and is comprised of five Nestlé Institutes: Food Sciences, Health Sciences, Food Safety & Analytical Sciences, Packaging Sciences, and Agricultural Sciences. For an overview of our research activities follow this link or read more about Nestlé...

  • Dee tenure Track Assistant Professor or Associate

    vor 4 Wochen

    Lausanne, Schweiz Université de Lausanne Vollzeit

    **Introduction**: UNIL is a leading international teaching and research institution, with over 5,000 employees and 17,000 students split between its Dorigny campus, CHUV and Epalinges. As an employer, UNIL encourages excellence, individual recognition and responsibility. **Presentation**: ***Tenure track Assistant Prof. or Associate Professor**: **in...

  • Pae6 - Trainee Clinical Trial Coordinator - 12

    Vor 4 Tagen

    Lausanne, Schweiz Debiopharm Vollzeit

    **_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop...

  • T2305 -non-clinical Data Manager - Translational

    vor 4 Wochen

    Lausanne, Schweiz Debiopharm Vollzeit

    **_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop...