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.
This position will serve as the Clinical Affairs business partner and interface with other functional areas and Team Members including but not limited to: assigned business units (BU), clinical operations, development, quality, global/regional marketing, regulatory affairs, PMS teams, medical writers, market access and the BCDM team. The Clinical Strategy Project Senior Lead will create clinical evidence requirements on specific products/brands and design studies to gather required clinical data in a cost effective, timely, and efficient fashion. Individual will work closely with Clinical Operations to ensure projects are aligned with business needs.
Principal Duties and Responsibilities
Implement proactive clinical evidence plans on products/brands based on Marketing/BU claims, regional needs, Market Access, Post Market Surveillance (PMS), and Regulatory Affairs needs.
Participate in PMS process as the clinical representative. May provide literature searches, registry data or study results for annual reports, notified bodies or other internal and external needs. Oversight of PMS commitments and aligning study outputs to PMS reviews.
Create Project Needs Documents for newly identified clinical research projects, including Health Care Provider (HCP) nominations and Maximum FMV analyses for Investigator Initiated Research studies.
Support development of clinical data summary by Clinical Evidence to meet tender/reimbursement requirements.
Proactively drive clinical research outcomes by developing publication strategies and plans.
Collate available clinical evidence for key products, and assist in delivering effective presentations on Zimmer Biomet products for multiple audiences.
Serve as a research services manager for select sites in conjunction with the External Research Process.
Expected Areas of Competence
Sets priorities consistent with company goals and focuses on high priority opportunities
Allocates resources (e.g. time, dollars) consistent with priorities
Outstanding organizational skills and attention to detail
Strong communication skills across all levels of the organization
Strong knowledge of applicable regulations governing clinical studies
Ability to assist and mentor other team members
Proficient in Microsoft Office Suite
Good Clinical Practice guidelines
Education/Experience Requirements
Bachelor’s Degree required; concentration in Health, Life Sciences, or Engineering preferred
Minimum of five years of experience in a clinical research environment, plus proficiency in Clinical Strategy Lead role
Travel Requirements
up to 20%
Additional Information
EOE/M/F/Vet/Disability
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.