
Senior Clinical Study Manager
Are you a highly experienced Clinical Study Manager with a passion for leading and executing innovative clinical trials? Do you thrive in a fast-paced environment and have a strong background in managing cross-functional teams? If so, we have an exciting opportunity for a Senior Clinical Study Manager at Stryker. As a global leader in the medical technology industry, Stryker is committed to improving patient outcomes through groundbreaking research and development. In this role, you will play a critical role in the success of our clinical studies by overseeing all aspects of study management and ensuring compliance with regulatory requirements. We are seeking a driven and detail-oriented individual with excellent communication and leadership skills to join our dynamic team. If you are ready to take your career to the next level and make a meaningful impact on patient lives, apply now for this exciting opportunity.
- Lead and manage all aspects of clinical studies, including planning, execution, and closeout phases.
- Ensure compliance with regulatory requirements and company policies.
- Develop and maintain study timelines, budgets, and project plans.
- Manage cross-functional teams, including clinical operations, data management, biostatistics, and medical affairs.
- Act as the primary point of contact for study sponsors, contract research organizations (CROs), and other external partners.
- Monitor study progress and identify and address any issues or risks.
- Collaborate with cross-functional teams to ensure timely and accurate data collection, analysis, and reporting.
- Ensure adherence to study protocols and standard operating procedures (SOPs).
- Manage study budgets and track expenses to ensure cost-effective execution.
- Provide regular updates and reports to senior management on study progress and results.
- Mentor and train junior staff on study management best practices.
- Stay current on industry trends and best practices in clinical trial management.
- Participate in the selection and management of external vendors and contractors.
- Coordinate and lead study-related meetings, including investigator meetings, monitoring visits, and data review meetings.
- Ensure patient safety and welfare throughout the duration of the study.
- Foster a collaborative and positive work environment within the study team.
- Assist with study site selection, feasibility assessments, and study start-up activities.
- Contribute to the development and review of study-related documents, such as protocols, informed consent forms, and clinical study reports.
- Communicate effectively with internal and external stakeholders, including study sponsors, regulatory agencies, and study sites.
- Adhere to all applicable laws, regulations, and ethical standards related to clinical research.
Minimum Of 7 Years Experience In Clinical Research, Preferably In The Medical Device Industry.
Strong Understanding Of Fda Regulations And Ich/Gcp Guidelines.
Proven Track Record Of Successfully Managing And Executing Multiple Clinical Trials, Including Budget And Timeline Management.
Experience In Leading Cross-Functional Teams And Working Collaboratively With Internal And External Stakeholders.
Bachelor's Degree In A Relevant Field, Such As Life Sciences Or Healthcare, With A Preference For A Master's Degree Or Above.
Risk Management
Communication Skills
Project Management
Vendor Management
Data Analysis
Time Management
Budget management
Team Leadership
Regulatory compliance
Clinical development
Clinical Trials
Contract Negot
Communication
Conflict Resolution
Leadership
Time management
creativity
flexibility
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Senior Clinical Study Manager in Raleigh, NC, USA is $95,000 - $150,000 per year. This may vary based on the specific company, experience level, and other factors.
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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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