Senior Clinical Study Manager

Stryker is seeking a highly experienced and dedicated Senior Clinical Study Manager to join our dynamic team. As a global leader in medical technology, Stryker is committed to improving patient outcomes and enhancing healthcare worldwide.In this role, you will be responsible for leading and managing clinical studies to support the development and commercialization of life-changing medical devices. We are looking for a strategic thinker with a strong background in clinical research, who is able to effectively collaborate with cross-functional teams and drive projects to successful completion.If you are a passionate and driven individual with a deep understanding of the clinical trial process and a desire to make a difference in the lives of patients, we encourage you to apply for this exciting opportunity at Stryker.

1. Develop and implement strategic plans for clinical studies to support the development and commercialization of medical devices.
2. Lead and manage all aspects of clinical trials, including protocol development, site selection, study start-up, monitoring, data collection, analysis, and reporting.
3. Ensure compliance with all applicable regulations and guidelines, including Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) standards.
4. Collaborate with cross-functional teams to define study objectives, timelines, and budgets, and ensure alignment with company goals and objectives.
5. Act as the primary point of contact for study sponsors, investigators, and contract research organizations (CROs), and maintain effective communication throughout the study.
6. Oversee study progress and identify and mitigate any potential risks or issues that may impact timelines or data quality.
7. Manage study budgets and timelines, and ensure efficient use of resources to meet study goals and objectives.
8. Develop and maintain study-related documents, including protocols, informed consent forms, study manuals, and clinical study reports.
9. Participate in the selection and management of study vendors, including CROs, central labs, and imaging vendors.
10. Provide leadership and mentorship to clinical study team members, and foster a collaborative and positive team environment.
11. Continuously evaluate and improve study processes and procedures to ensure efficient and high-quality execution of clinical studies.
12. Represent Stryker at external meetings, conferences, and scientific forums, and maintain awareness of industry trends and developments in clinical research.
13. Maintain accurate and timely study records and documentation, and ensure compliance with all internal and external reporting requirements.
14. Support regulatory submissions and responses to regulatory authorities, as needed.
15. Adhere to all company policies and procedures, and actively contribute to a culture of continuous improvement and operational excellence.

According to JobzMall, the average salary range for a Senior Clinical Study Manager in Minneapolis, MN, USA is between $100,000 and $125,000 per year. However, this can vary depending on factors such as experience, education, and the specific company or organization the individual is employed at.

Stryker Corp. is engaged in providing medical technology products and services. It operates through the following segments: Orthopaedics, MedSurg and Neurotechnology and Spine. The Orthopaedics segment provides reconstructive and trauma implant systems. The Medsurg segment deals with surgical instruments and equipment, endoscopy, patient handling, and reprocessed medical devices. The Neurotechnology and Spine segment pertains to spinal implants and neurovascular products.