Clinical Project Manager
vor 1 Monat
Clinical Project Manager
Teoxane Laboratories, a leading company in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics, is seeking a skilled Clinical Project Manager to join its team.
The ideal candidate will have a strong background in clinical operations and project management, with a minimum of 4 years of experience in the industry, especially in medical device clinical trials. The successful candidate will be responsible for implementing, executing, and completing clinical research projects sponsored by Teoxane according to timelines and budget.
Main Responsibilities
- Ensure compliance to local regulations, GCP regulations, and internal SOPs in clinical projects.
- Develop and manage the overall clinical study budget.
- Select and validate investigator/site, and vendors (i.e CROs).
- Contribute to the negotiation and preparation of contracts and budgets with third parties and sites participating in our studies.
- Responsible of the development of high-quality study documentation (i.e. from study protocol and study plans to final clinical study report) throughout the clinical study.
- Responsible of the management of Contract Research Organizations (CROs) and third-party vendors and ensure adherence to scope of work within timelines and budget.
- Able to work cross-functionally within the clinical team to monitor site performance (such as enrolment and compliance to study protocol), ensure high-quality data collection and review in clinical projects.
- Ensure that all relevant documents are properly and timely archived in the TMF during the study.
- Participate to the internal process improvements.
Your Profile
- Minimum B.Sc. degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science.
- Minimum of 4 years of experience in clinical operations; project management skills.
- Experience in industry, especially in medical device clinical trials is a plus.
- Strong critical thinking and problem solving skills.
- Strong negotiation, communication and presentation skills across all levels.
- Able to rapidly adapt to changing environment and circumstances.
- Fluent in English and French.
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