Manager, Clinical Research (Remote)

The Manager Clinical Research leads a team responsible for the planning execution and oversight of clinical studies supporting the safety and effectiveness of Strykers medical devices. This role drives operational excellence in clinical project management ensures compliance with regulatory requirements and partners cross-functionally to enable high-impact evidence generation aligned with business addition this role is responsible for the development of staff in the support of Strykers business objectives and timelines.

This position is ideal for a collaborative data-driven leader who thrives in a dynamic environment and is passionate about advancing patient outcomes through innovation in clinical research.

What you will do

• Develop and execute clinical research strategies processes and performance metrics that support organizational and regulatory goals.
• Contributes to the clinical strategy to demonstrate safety efficacy economic and quality of life outcomes for the performance of Stryker products and solutions. Lead mentor and develop a high-performing clinical project team.
• Foster a culture of accountability collaboration and continuous improvement.
• Oversee the planning execution and close-out of clinical studies (IDE post-market and observational).
• Ensure studies are completed on time within scope and in accordance with GCP ISO 14155 and applicable FDA/International guidelines.
• Maintain clinical timelines budgets and resource allocation plans; provide quarterly forecasts and variance analyses.
• Develops and provides oversight in the development of critical clinical study documents.
• Creates and maintains Clinical SOPs systems and processes across study trials
• Serve as a Subject Matter Expert (SME) for clinical processes and represent Clinical Affairs in internal and external audits.
• Supports and develops short-term and long-term planning and execution of clinical research including multi-center and investigator-initiated studies.
• Reviews evaluates and compiles files and reports for regulatory and reimbursement authorities.
• Develop strong customer and field personnel relationships ensuring appropriate sponsor oversight of clinical research centers
• Deliver site training updates and study communication materials to sites
• Strong clinical process acumen and ability to drive clinical excellence activities
• Partner with Regulatory Affairs Quality R&D Global Supply Finance Sales and Marketing to align clinical programs with strategic business priorities.
• Communicate study results progress and key insights to executive stakeholders.
• Provide input into product development and post-market surveillance activities.
• Prepares outlines summaries status reports etc. for distribution and communication with other departments and executive leadership
• Identify and implement process improvements to enhance clinical trial quality efficiency and compliance.
• Develop and track KPIs metrics and dashboards to monitor clinical performance and outcomes.

What you need

• Bachelors degree in Life Sciences Biomedical Engineering Nursing or related discipline.
• Minimum of 8 years of clinical research experience including 2 years of people management and/or leadership of critical clinical programs.
• Strong knowledge of FDA ISO 14155 and ICH/GCP clinical research regulations.
• Proven experience managing IDE and post-market medical device trials.

Preferred

• Advanced degree (MS MPH or equivalent) or certification in Clinical Research (CCRA CCRP etc.).
• Experience in both medical device and pharmaceutical industries.
• Demonstrated experience in data analysis trend reporting and audit readiness.
• Exceptional project and people management skills.
• Strong analytical and critical thinking capabilities.
• Demonstrated ability to lead through influence across diverse functions.
• Excellent communication presentation and collaboration skills.
• Proficiency in clinical trial management systems (CTMS) EDC platforms and electronic document management systems.
• Strong commitment to quality integrity and continuous improvement.
• Ability to thrive in a fast-paced evolving environment with multiple competing priorities.

• $ 121400.00 - $198600.00 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.
• Posted: October 30 2025