Clinical Engagement and Oversight Manager Europe
Inhoud van de functie
• Oversee all site engagement activities from the Sponsor side, including oversite monitoring visits, site retention visits, and MSL site visits.
• Develop and maintain strong relationships with clinical trials sites including principal investigators.
• Serve as a specialized site monitor to conduct over-site monitoring visits to existing trial monitors to verify adherence to monitoring plan and study protocol. Report any issues with site monitoring to CRO or Sponsor and devise a plan to correct deficiencies and see that they are corrected.
• Support the clinical sites with up-to-date product information and provide advice and work on site levels plans to improve site activities like patient enrollment or retention.
• Attend national and regional medical meetings and symposia as a representative of the company and engage in discussions with site staff related to study protocol information and specific site activities or happenings.
• Support clinical development initiatives including site identification, trial recruitment.
• Maintain a thorough awareness of medical/clinical, regulatory, compliance, and quality issues and processes and support the standards established by the company.
Functie eisen
- Bachelor’s degree in a scientific discipline.
- 10+ years of clinical trial monitoring experience with a verifiable record of high performance.
- Prior experience in cardiology, lipidology, endocrinology is preferred.
- Excellent interpersonal communication and presentation skills (including networking).
- Able to participate in a scientific dialogue with site investigators, KOLs and researchers.
- Excellent teaching skills and ability to present and discuss scientific material clearly and concisely.
- Skilled in clinical research and an understanding of the process of pharmaceutical product development and approval.
- Travel within Europe, first focus is on Ploand Hungary and Slovakia, but also other countries will be involved
- Demonstrated ability to organize, prioritize, and work effectively with minimal supervision in a constantly changing environment.
Onze opdrachtgever
Is a Dutch start up with potential. The client offers a hands on environment with plenty of room to work independently and contribute insights. The client has a cardiovascular drug in the pipeline, and the study results so far are very promising.
Headquarters are located in the Netherlands.