Global Clinical Operations Manager
1 giorno fa
Company Overview
Johnson & Johnson is a multinational healthcare company that develops medical devices, pharmaceuticals, and consumer packaged goods.
We are seeking a highly skilled Global Clinical Operations Manager to join our Medical Affairs team in Milano, Italy.
Job SummaryThe successful candidate will be responsible for coordinating operational activities for company-sponsored studies, ensuring timely delivery, and maintaining high-quality standards.
This role will act as incremental support to the Global Trial Lead, providing study/program coordination and regional/local expertise to assigned studies under the leadership of the GTL.
Key Responsibilities- Study Site Selection and Enrolment:
- Contribute to country and site selection processes
- Establish enrolment commitments plans for assigned regions/countries
- Ensure robust recruitment/contingency plans for assigned regions/countries
- Study Management & Progress:
- Develop project plans for assigned tasks as part of overall study plan
- Ensure required reports are generated and available for real-time tracking of study status
- Ensure timely and accurate documentation and communication of study progress
- Financial Planning and Tracking:
- Support GTL in study budget planning
- Monitor budgets and expenditures according to agreed study budget
- Ensure continuous forecasting for assigned tasks
- Document Development and Updates:
- Create and update study-specific plans and documents (e.g. monitoring guidelines, informed consent form)
- Provide input into cross-functional documents (e.g. safety-related documents)
- Training and Investigator Meetings:
- Contribute to planning and coordination of investigator meetings
- Ensure creation of appropriate study-specific training materials and requirements
- Cross-functional Study Management:
- Act as primary contact person for assigned tasks
- Establish and maintain excellent working relationships with internal stakeholders
- Continuous Quality Focus:
- Ensure compliance with applicable local regulations and internal operating procedures
- Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned tasks
Education:
BS degree or equivalent experience required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Experience and Skills:
- Minimum 5 years clinical study/program operations experience in the pharmaceutical industry or CRO
- Clinical research operational knowledge, strong project planning/management expertise, effective communication skills
- Experience and ability in coordinating teams in a virtual and matrixed environment
Johnson & Johnson offers a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
Others:Will travel occasionally with overnight stays depending on region.
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