Global Study Manager - Cell Therapy
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. You may be based in Gaithersburg, MD or Waltham, MA and will report to the Director, Study Management Cell Therapy.
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
- Contribute to the development of study documents
- Lead the preparation of country-specific agreements
- Manage third-party vendors
- Provide input to data management documents
- Ensure the supply of study materials
- Oversee third-party vendors, global / local internal staff, and investigator sites to support effective delivery of a study
- Monitor study conduct and progress
- Support risk management and quality efforts
- Assist 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
- Commissions for sales 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
Number of Employees
5,001-10,000 employees
