Senior Clinical Project Manager
- Experience Level
- Experienced (non-manager)
I am currently exclusively partnered with a unique dynamic medical device company that is now seeking a talented, dynamic Product Manager to join our team in Geneva, Switzerland. The Product Manager will work directly with Engineering, Sales and Operations, and will be responsible for the product life cycle management of the products in their portfolio.
The Clinical and Scientific Affairs Group is responsible for the design, regulatory submission and conduction of pre- and post-marketing clinical trials, to evaluate safety and performance for products.
- The Clinical Project Manager (CPM) will participate at sponsored and supported clinical studies, by contributions from early phase of study preparation through study conduct and study closeout in compliance with Good Clinical Practices, and all National and Local
- The successful candidate will act as study and project manager for studies of moderate to high complexity, ensuring high quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within
Your main responsibilities
- Contributes to study protocol
- Interfaces with clinical data management and statistics in developing case report forms, managing data clean-up, and analysing study data.
- Develops project plan and budget/schedule in collaboration with other participants/contributors.
- Oversees site selection and
- Trains and oversees monitoring teams (CRAs) and the timeliness and quality of their
- Oversees study vendors (reference labs, CRO, other potential vendors).
- Obtains and reviews and approves study
- Maintains study master file and all relevant study documentation. Performs study execution and status reporting
- Oversee study closeout activities and contributes to the final clinical study
- Contributes to department/function continuous improvement activities/initiatives.
- Medical or science education: Bachelor’s degree equivalent or higher qualification within Medicine, Bioengineering, Biological Science, Pharmacology or a relevant life sciences discipline
- Minimum 3 years of recent experience in clinical study management within medical device industry (Spine would be an advantage). Experience with class II & III medical devices preferred.
- Preferred experience includes clinical trials, post market studies, study monitoring, safety reporting, submissions, report writing, literature reviews, study budget management.
- Knowledge and experience of Good Clinical Practice (GCP) and regulations relating to medical device studies. Knowledge of additional/local regulations in different countries a plus.
- Project management skills required to include the use of a formal process and system for planning and tracking ongoing progress of clinical
- CRO and other Vendor management experience is an
- Good communication skills including the ability to present complex information to both clinical and non- clinical
- The Clinical Project Manager is expected to travel approximately 25% of the
- Fluency in English, any other language is an
If you are interested in this challenging career opportunity, in a dynamic growing and technology driven environment, we look forward to receiving your application.