Clinical Study Manager

The Clinical Study Manager is responsible for the daytoday operational management of one or more clinical studies including Investigational Device Exemption (IDE) postapproval postmarket surveillance feasibility marketing and investigatorinitiated studies in support of the Trauma & Extremities Division. This role partners crossfunctionally to ensure studies are executed efficiently compliantly and with high data quality to support evidence generation across the product lifecycle. The position is Remote with preference given to candidates located Eastern Standard Time (EST).

What you will do

• Manage the daytoday operational execution of clinical studies (IDE postapproval postmarket feasibility marketing and investigatorinitiated).
• 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 closeout 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 highquality study outputs.
• Track enrollment timelines milestones risks and deliverables; maintain study dashboards and reports.
• Partner with crossfunctional teams to identify and mitigate study risks and adapt to changes in scope or priorities.
• Manage InvestigatorInitiated and Strykersponsored 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 Strykers research strategy.

What you need

• Bachelors 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.

Preferred

• Experience in Device or Pharmaceutical industry.
• Clinical research or project management certification (e.g. CCRP ACRP PMP).
• Strong communication and presentation skills (articulate and persuasive).
• Strong organizational and project management skills with a high sense of attention to detail.

• $ 95700.00 - 159500.00 USD salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.

Posted: January 31 2026