
Senior Clinical Study Manager
Are you a highly skilled and experienced Clinical Study Manager with a passion for making a positive impact in the healthcare industry? Stryker is seeking a Senior Clinical Study Manager to join our dynamic team. In this role, you will be responsible for overseeing all aspects of clinical studies, from protocol development to final data analysis. We are looking for a driven and detail-oriented individual who is dedicated to delivering high-quality results and ensuring compliance with regulatory standards. If you have a strong background in clinical research and a desire to contribute to the development of innovative medical solutions, we want to hear from you!
- Oversee all aspects of clinical studies, including protocol development, study design, and data analysis.
- Ensure compliance with regulatory standards and guidelines, including FDA regulations and Good Clinical Practice (GCP).
- Develop and maintain study timelines, budgets, and resources.
- Lead and manage a cross-functional team of internal and external stakeholders, including investigators, study coordinators, and vendors.
- Collaborate with cross-functional team members to develop study protocols, informed consent documents, and other study-related documents.
- Monitor study progress and identify and address any potential issues or risks.
- Communicate study updates and progress to internal and external stakeholders.
- Manage study budgets and resources to ensure efficient and effective use of company resources.
- Conduct and/or oversee study site visits to ensure protocol compliance and data integrity.
- Ensure timely and accurate data collection, management, and analysis.
- Develop and maintain relationships with key opinion leaders and external partners to support study recruitment and execution.
- Provide guidance and mentorship to junior team members.
- Stay current with industry trends and best practices in clinical research and apply them to study management.
- Participate in the development and implementation of standard operating procedures (SOPs) to ensure consistency and efficiency in study management.
- Contribute to the development and review of study-related documents, such as clinical study reports, regulatory submissions, and publications.
- Maintain accurate and complete study documentation and records.
- Represent the company at conferences, meetings, and other industry events.
- Collaborate with cross-functional teams to support the development and commercialization of innovative medical solutions.
- Ensure the ethical conduct of clinical studies and protection of study participants' rights and welfare.
- Contribute to the continuous improvement of study processes and procedures.
Advanced Degree In Clinical Research: A Senior Clinical Study Manager At Stryker Should Have A Minimum Of A Master’s Degree In A Relevant Field Such As Clinical Research, Life Sciences, Or A Related Discipline.
Extensive Experience In Clinical Trial Management: The Ideal Candidate Should Have A Minimum Of 5 Years Of Experience In Managing Clinical Trials, Preferably In The Medical Device Industry. This Includes Experience In All Phases Of Clinical Research, From Study Startup To Closeout.
Strong Leadership And Project Management Skills: The Senior Clinical Study Manager Will Be Responsible For Leading A Team And Managing Multiple Projects Simultaneously. Therefore, They Should Possess Excellent Leadership And Project Management Skills To Ensure Timely And Successful Completion Of Studies.
In-Depth Knowledge Of Regulatory Requirements: Stryker Is A Global Company, And The Senior Clinical Study Manager Should Have A Thorough Understanding Of International Regulatory Requirements For Clinical Trials. This Includes Knowledge Of Fda Regulations, Ich Guidelines, And Other Relevant Standards.
Excellent Communication And Interpersonal Skills: The Senior Clinical Study Manager Will Work With Cross-Functional Teams, Including Physicians, Regulatory Affairs, And Data Management. Therefore, Strong Communication And Interpersonal Skills Are Essential For Effective Collaboration And Building Relationships With Team Members.
Quality Assurance
Project Management
Vendor Management
Data Analysis
Clinical Research
Budget management
Report Writing
Team Leadership
Risk assessment
Regulatory compliance
Patient Recruitment
Protocol Development
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
Critical thinking
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Clinical Study Manager in Chicago, IL, USA is between $120,000 to $150,000 per year. This may vary depending on the specific company, years of experience, and other factors. Some companies may also offer additional benefits such as bonuses, stock options, and healthcare benefits.
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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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