Clinical Study Manager

Stryker•Raleigh, NC

3d•Remote

About The Position

The Clinical Study Manager is responsible for the day‑to‑day operational management of one or more clinical studies, including Investigational Device Exemption (IDE), post‑approval, post‑market surveillance, feasibility, marketing, and investigator‑initiated studies, in support of the Trauma & Extremities Division . This role partners cross‑functionally to ensure studies are executed efficiently, compliantly, and with high data quality to support evidence generation across the product lifecycle. The position is R e mote , with preference given to candidates located Eastern Standard Time (EST).

Requirements

Bachelor's level degree or equivalent in science or health care field with at least 4 years of relevant clinical research experience, preferred in clinical study management.
Demonstrated success in assisting in solving complex strategies across multiple functions within the department in support of conducting multiple global clinical trials across multiple franchises.
Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, as well as preparation of clinical documentation in support of regulatory submissions.
Strong communication and presentation skills (articulate and persuasive).
Strong organizational and project management skills with a high sense of attention to detail.

Nice To Haves

Experience in Device or Pharmaceutical industry.
Clinical research or project management certification (e.g., CCRP, ACRP, PMP).

Responsibilities

Manage the day‑to‑day operational execution of clinical studies (IDE, post‑approval, post‑market, feasibility, marketing, and investigator‑initiated).
Contribute to study design and planning, including protocols, amendments, CRFs, monitoring plans, and operational procedures.
Ensure clinical study activities comply with regulatory requirements, internal processes, and data management standards.
Oversee study startup through close‑out, maintaining accurate and complete Trial Master File documentation.
Coordinate and support site monitoring activities, ensuring data quality, consistency, and timely issue resolution.
Lead data collection, validation, and system testing activities (e.g., eCRF/UAT) to support high‑quality study outputs.
Track enrollment, timelines, milestones, risks, and deliverables; maintain study dashboards and reports.
Partner with cross‑functional teams to identify and mitigate study risks and adapt to changes in scope or priorities.
Manage Investigator‑Initiated and Stryker‑sponsored studies, including contracts, deliverables, and registry/database engagement.
Collaborate with Legal and Finance to ensure compliant contract execution and investigator reimbursement.
Drive evidence generation by supporting analysis, publication, and presentation of study results.
Independently manage multiple studies while prioritizing workload and delivering results aligned with Stryker’s research strategy.