Global Study Manager
About The Position
Join us as a Global Study Manager in Cell Therapy, where you will be responsible for supporting the delivery of cell therapy clinical studies ensuring quality and compliance. This role requires a high degree of flexibility as the exact accountabilities will differ depending on the nature of the clinical program or study. As a Global Study Manager, you will contribute to the development of study documents, lead the preparation of country-specific agreements, manage third-party vendors, provide input to data management documents, and ensure the supply of study materials. You will also oversee third-party vendors, global / local internal staff, and investigator sites to support effective delivery of a study. Your role will involve monitoring study conduct and progress, support risk management and quality efforts, and assisting in the implementation of audits and regulatory inspections.
Requirements
- Bachelor’s degree with 4+ years of experience as a study manager
- Experience of working with and delivering through strategic partners and 3rd party vendors
- Excellent knowledge of ICH-GCP principles
- Ability to lead, coordinate and prioritize multiple tasks and deliverables
- Vendor Management experience
- Proactive approach to achieving study goals
- Demonstrated verbal and written communication skills
- Good negotiation and collaboration skills
- Demonstrated interpersonal and problem-solving skills
- Ability to manage change with a high degree of flexibility
Nice To Haves
- Early/late phase oncology clinical trial experience
- Experience in autologous or allogeneic therapies
- Clinical Study Management experience
Responsibilities
- Supporting the delivery of cell therapy clinical studies ensuring quality and compliance.
- Contributing to the development of study documents.
- Leading the preparation of country-specific agreements.
- Managing third-party vendors.
- Providing input to data management documents.
- Ensuring the supply of study materials.
- Overseeing third-party vendors, global / local internal staff, and investigator sites to support effective delivery of a study.
- Monitoring study conduct and progress.
- Supporting risk management and quality efforts.
- Assisting in the implementation of audits and regulatory inspections.
Benefits
- Eligibility for various incentives
- Opportunity to receive short-term incentive bonuses
- Equity-based awards for salaried roles
- Qualified retirement programs
- Paid time off (i.e., vacation, holiday, and leaves)
- Health coverage
- Dental coverage
- Vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
