Clinical Project Lead

Vor 3 Tagen

Winterthur, Schweiz Zimmer Biomet Vollzeit

-Requisition Number
EMEA10120
Employment Type
Full-time
Location
Winterthur

**What Is It Like To Work at Zimmer Biomet**:
At **Zimmer Biomet**, we believe in **The Power of Us**, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.

**Zimmer Biomet Offers You An Exciting Position With Good Career Prospects in a Fast-growing International Business, And a Competitive Remuneration Package**
- Possibility to grow, develop, and be promoted within a Team
- Friendly, warm and creative atmosphere
- Healthy, inspiring, and international work environment
- Ongoing coaching and talent development
- Access to future career opportunities
- Hybrid work model
- Competitive reward packages
- Annual bonus
- Social and CSR events
- Wellbeing initiatives

**What You Can Expect**:
The Clinical Project Lead (CPL) is responsible for broad aspects of clinical study development, initiation, monitoring and management. In addition and as requested by other teams especially by Clinical Strategy or Post Market Surveillance, the CPL will support new product development by counseling the team on relevant clinical aspects that needs to be taken into consideration during the development phase as well as by writing Clinical Evaluation Reports needed to supporting regulatory submissions.

**How You Create Impact**:

- Responsible for broad aspect of clinical study development and support
- Clinical studies include regulatory approval monitored studies, prospective randomized control trials and mono
- and multicenter outcomes studies (Post-Market Surveillance)
- The support includes site start-up, data quality maintenance, report generation and presentation development
- Conduct site visits including site assessment, interim monitoring for appropriate patient enrollment and documentation compliance and close out or termination visits
- Lead presentation of study design, clinical program and contractual agreements to potential investigators
- Conduct training of research coordinators and surgeon office staff on data collection methods
- Support submission of protocols to ethics committees and competent authorities for review and approval
- Collaborate with biostatisticians to design study databases, evaluate data and assist in producing surgeon requested analysis and presentations on clinical results
- Consult with marketing and engineering staff concerning risk analysis, clinical assessments, clinical projects status, and results of the clinical trials
- Consult with independent radiologists, and other outside consultants as required for study progress
- Build strong relationships with surgeons and research staff involved in clinical research
- Support regulatory and development efforts during the conformity assessment process (FMEA, Risk Management and PMS plan and report), as applicable
- Perform literature research for study development, protocol development, case report form design and development of patient information and consent forms, as applicable
- Write Clinical Evaluation Reports needed for regulatory submissions, as applicable

**What Will Make You Stand Out**:

- Minimum of a Bachelor of Science Degree or equivalent education in technical area (biomedical sciences or engineering, medical or biology, etc.) with a preference for an advanced degree (PhD, MD)
- Fluent written and spoken English is a must
- Preferred multilingual

**What Will Make You Successful**:

- Advanced Microsoft Office Suite and general computer software skills
- Preferred previous experience in clinical research of medical devices with direct responsibility for protocol submissions, development and content
- Research / Technical publication and/or technical writing experience beneficial
- Knowledge of medical device business, products, medical education and product development preferred
- Possess strong oral and written communication skills
- Self motivated Team-player, happy to work as part of an extended Team

**Who We Are**:
**Zimmer Biomet** is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to _alleviating pain and improving the quality of life for people around the world_.
- Looking to make an impact? Join us and make a difference._

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