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Vacancy : Clinical Strategy Manager – Fully Remote/Virtual Office
Company Location : Remote
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.
Primary responsibilities for the Clinical Strategy Manager include developing, maintaining, and executing clinical evidence plans for new and existing products within the Product Engine. The senior manager reports into the product engine, and interacts with Clinical Operations and PE marketing and development leads to identify clinical research needs and develop execution and monitoring plans to ensure that required clinical evidence is gathered in an ethical manner and communicated in a timely fashion.
The Clinical Strategy Manager will have primary responsibility for the development and direction of clinical research strategy for key product lines and programs within the product engine. Responsibilities include identification of research needs, identifying and negotiating with research centers, development of protocols and research plans, oversight of contracting with research centers, budget development and negotiation, quality assurance and monitoring of study progress, and dissemination of research products including reports, whitepapers, and manuscripts for publication. Routine interactions with health care professionals, and internal stakeholders including PE management, Clinical Operations and Biostatistics staff, Regulatory Affairs, and Compliance as required to facilitate the clinical research strategy and research program.
Principal Duties and Responsibilities
Proactively develops and maintains clinical evidence plans on PE products, brands, and brand variants. Interacts with HCPs, PE, and Clinical Operations to develop appropriate, cost effective, and impactful plan elements.
Oversees both internally managed and investigator initiated research to ensure timely collection and delivery of clinical data in support of regulatory requirements and marketing strategies.
Demonstrated expertise and strong understanding of the overall project goals, the indication (s) studied and the purpose of the planned studies in meeting the objectives of the project, assist in the development of the clinical plan.
Analyzes and identifies critical evidence gaps in support of post market surveillance needs, and provides strategy for clinical evidence gap filling through timely and cost effective research programs.
Organizes and oversees clinical advisory panel meetings with key opinion leaders as a means of developing and executing clinical research strategy.
Collates available clinical evidence for key products, and develops and delivers effective presentations to health care professionals in one-on-one meetings and/or developer team meetings.
Contributes to the development of clinical evidence summaries to support tenders, regulatory submissions, and/or surgeon communications.
Develops publication plans for key clinical projects to ensure that clinical results are disseminated in an appropriate and timely fashion.
Expected Areas of Competence
Demonstrated expertise and strong understanding of product function, features and benefits, marketing strategy, competitive devices, and clinical evidence needs globally.
Ability to communicate strategic needs to internal and external stakeholder in a manner that helps guide clinical research implementation.
Has a thorough understanding of ethical principles of clinical research, and strong insight into regulations and requirements governing the conduct of clinical research globally.
Has strong knowledge in clinical research designs and data analysis, and regulatory and journal requirements for publications.
Communicates effectively in all settings with internal and external stakeholders.
A minimum of a Bachelor’s degree in health, life sciences, or engineering required
A minimum of 6 years of experience clinical research in medical devices required
Previous direct clinical study design, FDA/Notified Body interaction and negotiation, and study launch and clinical monitoring experience required
Previous demonstrated experience in, and responsibility for study budget, enrollment, inventory and progress reporting required
Up to 30%
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.
Compensation Range: $116,000 – $137,000
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