Clinical Project Manager

Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and cosmeceuticals. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore youthful volume to the face, and to treat the neck and décolleté, with natural results. The strength of Teoxane is also its human size and independence. Teoxane has a total freedom of thoughts, action and innovation which makes the company unique.

In the frame of the growth of our business, we are looking for a:

Clinical Project Manager

Job Summary:

 

Part of the clinical research department, this role will be responsible of implementing clinical studies to ensure compliance with the FDA Regulations and its recent updates. The Clinical Project Manager will be planning and managing in accordance with time, budget and quality standards clinical studies within a young and dynamic environment.

Responsibilities:

• Implementation, execution and completion of clinical research projects sponsored by Teoxane according to timelines and budget.
• Responsible of the compliance to local regulations, GCP regulations, and CRO SOPs in clinical projects
• Selection and validation of investigators/sites, and vendors (i.e., CROs)
• Contributing to the negotiation and preparation of contracts and budgets with third parties and sites participating in our studies
• Responsible of developing and ensuring high quality documentation (i.e., from study protocol and plans to final clinical study report) throughout the clinical study.
• Oversight and development of essential clinical documentation for regulatory and ethic committee submissions in United States.
• Responsible for management of Contract Research Organizations (CROs) and ensure their adherence to scope of work within timelines and budget
• Management of clinical study budgets including site agreements/budget
• Oversight of CRO’s monitor performance and /or perform co-monitoring visits in sites participating to clinical projects sponsored by Teoxane
• Communicate regularly with sites participating to clinical projects sponsored by Teoxane
• Ensure high quality data collection in clinical projects
• Ensure that all relevant documents are properly archived in the TMF during the study
• Participation to internal process improvements

 

Qualifications and Job Specifications:

• Minimum B.Sc. degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
• Minimum of 2 years of experience in clinical operations and project management skills
• Experience in industry, especially in medical device clinical trials is a plus
• Strong critical thinking and problem-solving skills
• Good negotiation, communication, and presentation skills
• Able to rapidly adapt to changing environment and circumstances
• Fluent in English and French