Global Study Manager, Cell Therapy
About The Position
This role is responsible for supporting the delivery of cell therapy clinical studies, ensuring quality and compliance. The position requires a high degree of flexibility as accountabilities will differ based on the clinical program or study. The Global Study Manager 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. The role also involves overseeing third-party vendors, global/local internal staff, and investigator sites to support effective study delivery. Responsibilities include monitoring study conduct and progress, supporting risk management and quality efforts, and assisting in the implementation of audits and regulatory inspections. The role may be based in Gaithersburg, MD or Waltham, MA.
Requirements
- Bachelor’s degree with 4 + years of experience as a study manager
- Experience 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
- 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
Senior
