Clinical Research Project Manager - Oberdorf / Zuc
Jocelyn Blackham is recruiting for a Clinical Research Project Manager to join a company in the Medical Device industry at their site based in Oberdorf or Zuchwil on a contract basis for 12 months.
The main purpose of the role will be to:
- Play a key role in the development of post-market clinical research strategies of orthopaedic devices to support global regulatory and post-market surveillance requirements
- Work closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to develop post market evidence generation strategies that consider global evidence needs
- Maintain strong understanding of evolving post-market evidence requirements (i.e. FDA and EU Medical Device Regulation)
- Develop and draft Post-market Clinical Follow-up (PMCF) plans, clinical study protocols, registry plans, informed consents, investigator brochures, and other study materials with minimal supervision
- Foster relationships with surgeons, hospitals and research teams to gain input into study design, evaluate study feasibility, and identify sites for study execution or data collection
- Develop strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders
Further responsibilities will include:
- Drafting Post-Market Clinical Follow-up (PMCF) Reports and study reports with minimal supervision for assigned studies to include any annual reports, study close out reports as well as clinical sections for regulatory submissions
- Supporting clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, and communicate evidence
- Developing a strong understanding of the orthopaedic device product portfolio and business needs for clinical evidence to meet regulatory requirements
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Previous experience in the Medical Device industry is required
- A Bachelor's degree in Biological Science or related discipline, with related scientific, technical, or clinical research experience
This is an excellent opportunity to join a global medical device company.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 41 727 6793 or email firstname.lastname@example.org. Please could you send any correspondence in English. Please quote reference QLS44568 in all correspondence.