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 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. Candidate will work closely with Clinical Operations to ensure projects are aligned with business needs
Principal Duties and Responsibilities
Implements proactive clinical evidence plans on products/brands based on Marketing/BU claims, regional needs, Market Access, Post Market Surveillance (PMS), and Regulatory Affairs needs.
Participates in PMS process as the clinical team member. 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.
Creates Project Needs Documents for newly identified clinical research projects, including Health Care Provider (HCP) nominations and Maximum FMV analyses for Investigator Initiated Research studies.
Supports development of clinical data summary by Clinical Evidence to meet tender/reimbursement requirements.
Drives proactively clinical research outcomes by developing publication strategies and plans.
Collates available clinical evidence for key products, and assists in delivering effective presentations on Zimmer Biomet products for multiple audiences.
Serves 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
Proficient in Microsoft Office Suite
Good Clinical Practice guidelines
Bachelor’s Degree required; concentration in Health, Life Sciences, or Engineering preferred
Minimum of five (5) years of experience in a clinical research environment
Up to 20%
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.