Stryker is seeking a Manager, Clinical Research to oversee clinical trial operations, ensuring compliance with regulations, managing site and vendor selection, and preparing budgets. The manager will lead research initiatives, collaborate with international teams, and ensure high-quality, impactful results in healthcare.
Requirements
- Minimum of 8 years of experience in a regulated environment, including at least 2 years in a management role
- Experience in the medical device industry
- Strong knowledge of Good Clinical Practices (GCP), clinical trial design, and project management
- Experience with Investigational Device Exemption (IDE) and post-market clinical trials
- Familiarity with clinical regulatory requirements, including ISO standards, FDA regulations, and international guidelines
Responsibilities
- Oversee the planning and execution of global clinical studies, ensuring alignment with regulatory and ethical standards.
- Serve as a subject matter expert during audits and regulatory interactions.
- Manage clinical study budgets, forecasts, and resource planning.
- Ensure timely delivery of study milestones, including data collection, monitoring, and reporting.
- Develop and implement tools, systems, and processes to optimize clinical operations.
- Monitor team performance, define KPIs, and foster continuous improvement and engagement.
Other
- Remote position located within the United States, Eastern or Central time zone only.
- Lead, mentor, and develop a high-performing team of clinical research professionals.
- Collaborate with internal stakeholders (e.g., R&D, Marketing, Market Access) and external partners (e.g., CROs, investigators) to drive study success.
- Travel Percentage: 40%
