Program SaVIE (VIE of Sanofi) is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.
PLEASE NOTE that since the VIE Program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.
PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered.
We are looking for a candidate for a VIE mission of:
Clinical Trial Junior Study Manager - VIE Contract (W/M)
The Clinical Trial Junior Study Manager is responsible for the overall project management of Investigator Sponsored Studies (ISS) for assigned drug programs globally. Junior Study Manager is able to work independently and is responsible for ensuring studies are run in compliance with GCPs, SOPs and local regulations. She or he is also responsible for overseeing and managing the timely execution of contracts and financial payments, budgeting and financial forecasting in Genzymeinance systems, tracking ISS study progression, managing the ISS database, and for maintaining ongoing metrics and reports on a regular basis.
Responsibilities include: - Proactively manage ISS through the approval and contract negotiation stages
- Metrics reporting: prepare and track ISS cycle times and make recommendations for process changes
- Working with Regulatory to generate cross reference letters and ensure all regulatory documents for studies are in place
- Working with Legal to generate contracts and CDAs
- Responsible for forecasting study drug requirements
- Tracking budgets and financial reporting including invoice and PO management/reconciliation, accrual tracking and reporting and re-forecasting with finance
- Corresponding with sites to provide updates on ISS status pre-approval
- Maintain communications with Genzyme Pharmacovigilance for drug safety updates and distribute formal update letters to investigator sites as needed
- Ensure ISS records and history are audit ready
- Participate in process improvement and development: SOP development, training, process, and other departmental activities
Knowledge and Skills: - Master Degree in Life Science, Ph. D. welcome
- Prior successful Clinical Trial experience
- Strong analytical and problem solving skills
- Works independently
- First experience in clinical development, FDA regulations and ICH/GCP guidelines
- Knowledge of industry standards and practices preferred
- Excellent interpersonal and communication skills, including medical terminology and ability to deal with senior stakeholders
- Strong organizational and time management skills
- Self-motivation
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
