Senior Research and Development Clinical Associate

vor 4 Wochen

Lausanne, Waadt, Schweiz Pharmiweb Vollzeit

The Senior Research and Development Clinical Associate will oversee daily operations at investigational sites across Europe for our groundbreaking structural heart valve pivotal trial. This includes ensuring compliance with international guidelines, local regulations, and company policies.

About the Position

This is a pivotal role in managing a global trial, advancing a cutting-edge therapy, and contributing to the company's mission of pioneering MedTech innovation. As a Senior Research and Development Clinical Associate, you will be responsible for ensuring the success of our trial, advancing our therapy, and fostering a collaborative and dynamic work environment.

Key Responsibilities

  • Oversee vendor activities and participate in study start-up and conduct.
  • Lead investigations into discrepancies in study documentation.
  • Conduct reviews of documentation for internal and external audits.
  • Train site personnel and vendors on study protocols and regulatory requirements.
  • Assess data documentation, reports, and records for consistency and compliance.
  • Verify trial data and ensure proper regulatory documentation is maintained.

Qualifications

  • Bachelor's degree in a relevant field with 5+ years of clinical trial monitoring experience.
  • Medical device experience, with strong preference for Class III cardiovascular devices.
  • Experience with site- and sponsor-level audits.
  • Excellent communication, presentation, interpersonal, and analytical skills.
  • Experience working with CROs, core labs, and external vendors.
  • Proven problem-solving, critical thinking, and attention to detail.
  • Expertise in MS Office suite and Adobe applications.
  • Experience with Electronic Data Capture Systems (EDC) required.
  • Thorough knowledge of GCP and working knowledge of relevant regulations.
  • Clinical research certification preferred.
  • Up to 50% travel across Europe required.
  • Fluency in English. Fluency in French and German a plus, other EU languages a benefit.

Competitive Benefits Package

  • Competitive salary: $120,000 - $180,000 per year, performance-based bonuses, and stock options.
  • Comprehensive benefits package.
  • Career development opportunities in a growing and innovative company.

About the Company

The company is a global company with offices in the US, Switzerland, and Australia. We foster a collaborative and dynamic work environment with a culture of innovation and excellence.

Location

Please note: Due to privacy restrictions, we are unable to disclose the specific location of this role. However, qualified candidates with fluency in additional European languages are strongly encouraged to apply.

About Us

We are a pioneering MedTech company developing the first-in-class structural heart valve. If you are passionate about advancing healthcare and eager to contribute to a groundbreaking therapy, we encourage you to apply.

  • Global Clinical Trials Manager

    vor 2 Wochen

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    About DebiopharmDebiopharm International SA is a privately-owned Swiss biopharmaceutical company dedicated to the research and development of innovative therapies for patients worldwide. Our unique "development only" business model enables us to bridge disruptive discovery products with patient access in international markets.We are seeking an experienced...

  • Senior Clinical Development Quality Manager

    Vor 4 Tagen

    Lausanne, Waadt, Schweiz Aixial Group Vollzeit

    OverviewAixial Group, a leading CRO in Life Science, is seeking a Senior Clinical Development Quality Manager to join its team. Located in Lausanne, Switzerland, this role offers the opportunity to work on clinical projects from phases I to IV and post-market, collaborating with laboratories to provide technical support. Salary & BenefitsWe offer a...

  • Senior Oncology Clinical Document Specialist

    vor 7 Stunden

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    Job DescriptionWe are seeking a highly skilled Senior Oncology Clinical Document Specialist to join our team at Debiopharm, a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases. The ideal candidate will have a strong background in clinical document development, regulatory compliance, and collaboration...

  • Clinical Research Officer

    vor 1 Monat

    Lausanne, Waadt, Schweiz Aixial Group Vollzeit

    Clinical Research Officer - GCP SpecialistJoin Aixial Group, a leading CRO in Life Science, and take on the role of Clinical Research Officer - GCP Specialist. Our team is dedicated to providing technical support on clinical projects from phases I to IV and post-market.We are a dynamic and growing company, with a strong presence in Switzerland, France,...

  • Data Scientist for Clinical Research

    vor 2 Wochen

    Lausanne, Waadt, Schweiz Aixial Group Vollzeit

    Clinical Research Professional with Specialized ExpertiseAixial Group, a leading CRO in Life Science, seeks a skilled professional to support clinical operations and regulatory affairs.Our team collaborates with laboratories to provide technical support on clinical projects from phases I to IV and post-market.As a specialist in GCP, you will contribute to...

  • Clinical Research Officer

    vor 6 Stunden

    Lausanne, Waadt, Schweiz Aixial Group Vollzeit

    Aixial Group is a leading Clinical Research Organization in Life Science, specializing in clinical projects from phases I to IV and post-market.We provide technical support to laboratories, operating in outsourcing, insourcing, and regulatory affairs, quality, biometrics, pharmacovigilance, and HEOR.Our international presence is expanding in Switzerland,...

  • Senior Clinical Development Quality Strategist

    vor 7 Stunden

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    Debiopharm International SA, an independent biopharmaceutical company based in Switzerland, seeks a highly skilled Clinical Development Quality Lead to support the implementation of its Quality Strategy.The ideal candidate will have a strong background in clinical quality management and a deep understanding of regulatory requirements. They will be...

  • Senior Clinical Operations Specialist

    vor 3 Wochen

    Lausanne, Waadt, Schweiz Aixial Group Vollzeit

    Aixial Group is a CRO (Clinical Research Organization) specialized in Life Science, providing technical support on clinical projects from phases I to IV and post market. Our team works with laboratories to deliver high-quality services.We are part of the Alten family and have been expanding our activities in Switzerland, France, Belgium, Czech Republic,...

  • Senior Clinical Trials Manager

    vor 4 Wochen

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    Debiopharm is a privately-owned Swiss biopharmaceutical company dedicated to research in oncology and infectious diseases, aiming to improve patient outcomes and quality of life. Our unique development-only business model serves as a bridge between innovative discovery products and patient access in international markets.You will be at the forefront of the...

  • GCP Officer – Clinical Research Expert

    Vor 4 Tagen

    Lausanne, Waadt, Schweiz Aixial Group Vollzeit

    Clinical Research Specialist OpportunityAt Aixial Group, we are a leading Clinical Research Organization (CRO) specializing in Life Science. Our team provides technical support for clinical projects from phases I to IV and post-market.We have been part of the Alten family since 2014 and have expanded our activities to Switzerland, France, Belgium, Czech...

  • Clinical Development Quality Lead

    vor 2 Wochen

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    About DebiopharmDebiopharm is a biopharmaceutical company based in Switzerland that focuses on developing innovative therapies for oncology and infectious diseases. Our mission is to improve patient outcomes and quality of life through our research and development efforts.Your RoleWe are seeking a Clinical Development Quality Lead to join our team. As a key...

  • Senior Pharmacometrician

    vor 4 Wochen

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    Debiopharm is a Swiss biopharmaceutical company dedicated to research in oncology and infectious diseases to improve patient outcomes and quality of life. Our unique "development only" business model enables us to act as a bridge between innovative discovery products and patient access in international markets.We are seeking a Senior Pharmacometrician to...

  • Senior Clinical Data Manager

    vor 1 Monat

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    Debiopharm is a Swiss biopharmaceutical company dedicated to research in oncology and infectious diseases to improve patient outcomes and quality of life.We are seeking a Senior Clinical Data Manager to join our Biometry organization at our Headquarters in Lausanne.The Senior Clinical Data Manager will be accountable for the quality and timelines of data...

  • Clinical Development Quality Lead

    vor 1 Monat

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    Join Debiopharm's Team as a Clinical Development Quality LeadDebiopharm, a pioneering biopharmaceutical company based in Switzerland, is seeking a highly skilled Clinical Development Quality Lead to join its dynamic team. As a key member of our Quality Management - R&D organization, you will play a crucial role in implementing our Quality Strategy and...

  • Senior Scientist, Analytical Development and Quality Assurance

    vor 1 Monat

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    About DebiopharmDebiopharm International SA is a privately-owned Swiss biopharmaceutical company dedicated to the development of innovative therapies for oncology and infectious diseases. Our commitment is to improve patient outcomes and quality of life through cutting-edge research and development.Job DescriptionWe are seeking a highly skilled Senior...

  • Medical Director Clinical Development Neurology Expert

    vor 2 Wochen

    Lausanne, Waadt, Schweiz headcount AG Vollzeit

    Clinical Development LeadAt headcount AG, we are seeking a Clinical Development Lead to play a pivotal role in leading the clinical development of innovative therapies targeting neurodegenerative diseases, including Alzheimer's and Parkinson's.This role is responsible for clinical strategy, trial design, and oversight, working closely with the biomarker and...

  • Global Clinical Trial Management Expert

    vor 7 Stunden

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    Job SummaryThis exciting opportunity is available for a skilled Global Clinical Trial Leader to join Debiopharm, a privately-owned Swiss biopharmaceutical company dedicated to advancing oncology research.Company OverviewDebiopharm International SA is committed to developing innovative therapies through our unique 'development only' business model. This...

  • Senior Pharmacometrician

    vor 4 Wochen

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    Debiopharm is a leading biopharmaceutical company committed to developing innovative therapies for oncology and infectious diseases. We strive to improve patient outcomes and quality of life through our research and development efforts.The Clinical Pharmacology & Pharmacometrics Unit at our Headquarters in Lausanne is seeking a highly skilled Senior...

  • Global Clinical Trial Manager

    vor 1 Monat

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    About DebiopharmDebiopharm is a privately-owned Swiss biopharmaceutical company dedicated to research in oncology and infectious diseases to improve patient outcomes and quality of life. Our unique "development only" business model enables us to act as a bridge between disruptive discovery products and patient access in international markets.Role OverviewWe...

  • Global Clinical Trial Manager

    vor 4 Wochen

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    Debiopharm is a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases to improve patient outcomes and quality of life. As a Global Clinical Trial Leader, you will be at the forefront of the fight against cancer and infectious diseases through innovative medicines for patients.About the RoleYou will lead a...