Ensure Project Management of the studies made responsible for and coordination of clinical team members who are involved in the study not limited to the following functions Pasteur Clinical Program, Clinical Supply Chain, Regulatory Affairs, Pharmacovigilance, other relevant stakeholders)
Responsible for ensuring that the clinical trials and the observational studies are executed in line with Vaccine strategy in terms of planning, budget and quality, and according to local and international regulations.
Prepare and manage the study Budget, negotiating fees and agreements. ( AED, Investigator’s/sponsor’s agreements/CRO’s agreement, etc.)
Contributes to the trial design, manages, and coordinates the planning, the feasibility/evaluation and the execution of clinical and observational studies performed as part of the Medical Action Plan.
Define and follow-up study planning (Company-sponsored & Externally sponsored)
Coordinate the Study risk management Plan, Review study documents such as protocol, CRF, ICF and etc.
Anticipate and book the product needed for the study when applicable (Company-sponsored & Externally sponsored)
Develop collaboration network, both external (Inv’s) and Internal with medical points of contact from the regions, support departments (Finance, Purchasing, CSU) and CSO when applicable
Mentor Trainees and VIEs on all processes and global tools
The Medical Clinical Project Manager also contributes significantly to Pasteur or Sanofi initiatives of Process harmonization/improvement.
Experience & Skills
6-10 years experience in clinical ,observational research and project management
Master in a health related field (Biology, Life science, Pharmacy), PhD degree or equivalent
Knowledge/ Formal training in GCP/GEP/GPP methods
Formal experience in Ph-Epidemio studies would be off advantage
Good understanding and knowledge of international environment, commercial constraints and company policy in terms of Quality and ethical standards
Leadership and team work skills to work across functions and manage operations
Ability to quickly learn and work independently while managing priorities and apply knowledge in complex concepts
Creative and strategic mind-set with ability to drive projects , solutions and initiatives forward
Decision making ability with ability to multitask around priorities
Good communication skills and fluency in English
Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.
At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.