Global Study Manager, Cell Therapy
$112,000–$168,000 year
On-site · Gaithersburg, Maryland, United States
Job Summary
Global Study Manager for Cell Therapy responsible for supporting delivery of cell therapy clinical studies with focus on study documents, country-specific agreements, vendor management, data-management inputs, and ensuring supply of study materials. Oversees third-party vendors, global/local internal staff, and investigator sites to support study delivery; monitors study conduct and progress; supports risk management and quality efforts; assists in audits and regulatory inspections. Based in Gaithersburg, MD and reports to the Director, Study Management Cell Therapy.
Required Qualifications
- Bachelor’s degree
- 4+ years of experience as a study manager
- Experience with strategic partners and third-party vendors
- Excellent knowledge of ICH-GCP principles
- Ability to lead, coordinate and prioritize multiple tasks
- Vendor management experience
- Proactive approach to achieving study goals
- Strong verbal and written communication skills
- Good negotiation and collaboration skills
- Interpersonal and problem-solving skills
- Ability to manage change with flexibility
- Some travel may be required
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