Hello and welcome to Stryker! We are a leading medical technology company dedicated to making healthcare better for patients around the world. Our team is currently seeking a highly motivated and experienced Clinical Study Manager to join our growing organization. As a Clinical Study Manager, you will play a crucial role in managing and overseeing clinical trials for our innovative medical devices. We are looking for a passionate and detail-oriented individual with a strong background in clinical research and project management. If you are ready to make a significant impact on the lives of patients and contribute to cutting-edge medical advancements, we invite you to apply for this exciting opportunity with Stryker.
- Manage and oversee all aspects of clinical trials for Stryker's medical devices, from planning to execution, in compliance with company and regulatory requirements.
- Develop and maintain study timelines, budgets, and resources to ensure efficient and timely completion of trials.
- Collaborate with cross-functional teams including medical affairs, regulatory affairs, and data management to ensure study objectives and timelines are met.
- Coordinate and lead study meetings, including investigator meetings, site initiation visits, and monitoring visits.
- Communicate regularly with key stakeholders, including study sites, sponsors, and vendors, to provide updates on study progress and address any issues that arise.
- Ensure study protocols, informed consent forms, and other study-related documents are accurate, complete, and in compliance with applicable regulations.
- Monitor study data to ensure quality and accuracy and work with data management to resolve any discrepancies.
- Manage study budgets and track expenses to ensure adherence to budgetary guidelines.
- Act as the primary point of contact for study sites and provide support and guidance throughout the duration of the trial.
- Ensure all study activities are conducted in accordance with Good Clinical Practice (GCP) and relevant regulations.
- Conduct risk assessments and develop risk mitigation strategies to ensure the safety and well-being of study participants.
- Oversee study close-out activities, including data cleaning, database lock, and study report writing.
- Keep up-to-date with industry trends and developments in clinical research and apply best practices to study management.
- Mentor and train junior team members to ensure their understanding of study protocols and processes.
- Represent Stryker at conferences and meetings related to clinical studies and present study updates and results as needed.
Bachelor's Or Master's Degree In A Related Field Such As Biomedical Sciences, Nursing, Or Clinical Research.
Minimum Of 3-5 Years Of Experience In Clinical Study Management, Preferably In The Medical Device Or Pharmaceutical Industry.
Strong Understanding Of Clinical Trial Regulations, Guidelines, And Best Practices, Including Fda And Ich Gcp.
Excellent Project Management Skills, With The Ability To Effectively Manage Timelines, Budgets, And Resources.
Proven Leadership Abilities, With Experience Managing Cross-Functional Teams And Driving Successful Project Outcomes.
Communication Skills
Project Management
Data Analysis
Time Management
Budget management
Team Leadership
Risk assessment
Regulatory compliance
Clinical Trials
Protocol Development
Good Clinical Practice (GCP)
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
self-motivation
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Clinical Study Manager in Kalamazoo, MI, USA is $81,000 - $123,000 per year. This range may vary depending on the specific company, experience level, and qualifications of the individual. Some additional factors that may impact salary include the size and scope of the clinical studies being managed, the specific therapeutic area or disease being studied, and the level of responsibility and leadership required in the role.
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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.

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