This job listing has expired and the position may no longer be open for hire.

Sr. Project Lead Clinical Strategy (661456) at Zimmer US in Warsaw, Indiana

Posted in Management 30+ days ago.

Type: Full-Time





Job Description:

Job Summary

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.





More jobs in Warsaw, Indiana

General Business
about 6 hours ago

The Kroger Co.
Other
about 22 hours ago

Zimmer Biomet
Other
about 22 hours ago

Zimmer Biomet
More jobs in Management

Management
about 1 hour ago

Jabil Inc.
Management
about 1 hour ago

Jabil Inc.
Management
about 1 hour ago

Thales USA, Inc. (AMS)
$150,000.00 per year