Description
We are looking for a
Clinical Project Manager Medical Devices (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in Central Switzerland/Swiss Plateau region
Branch: Herstellung von orthopädischen und prothetischen Erzeugnissen
Your tasks:
- Responsible for the day-to-day management of investigational (prä CE- Studies) clinical studies
- Responsible for the preparation, including coordining translations, of study protocols, informed consent forms, case report forms, and other study related documentation
- Works closely with data management group from study design through to reporting of results
- Create and maintain study timelines
- Manage study budget
- Organizes and leads internal meetings with associated communications
- Act as principle liaison between investigators, contract research organizations, central laboratories, and other study vendors
- Negotiates budget and contracts with investigators, central laboratories, and other study vendors
- Trains investigators, research coordinators, contract research organizations, central laboratories, and other study vendors on all study procedures
- Provides input on the reportability of adverse events and other clinical study issues to regulatory agencies
- Assists in the preparation of regulatory documents and submissions as needed
- Contributes to scientific publications in international peer-reviewed journals and other publications as appropriate
- Assists in improving department SOPs and policies
- Identify and implement process improvements
- Collaboration with internal customers including Research & Development, Quality Assurance, Regulatory and Product Teams
- Routine contact with clinical study surgeons and their staff
- Up to 20% travel, both domestically and internationally, required
Your qualifications
- Bachelor's Degree required
- Experience in medical device industry, clinical setting, or research field required
- Working knowledge of local and international regulations for conducting human clinical studies
- Ability to handle complex projects with great attention to detail
- Demonstrates problem solving and judgment skills
- Excellent understanding of Good Clinical Practices and current regulations regarding clinical studies
- Ability to participate in cross-functional teams, team player and contributor
- Demonstrates ability to perform assignments independently, and with high level of initiative in all aspects of work
- Excellent interpersonal and communication skills, both written and verbal. Strong verbal and oral presentation skills
- Professional, ethical and dedicated
- Experience working with Microsoft Office (Word, Excel, Outlook, Powerpoint)
Skills:
- Clinical project manager
- Clinical trial manager