Are you ready to make a bold move in your career? 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 will be based in Gaithersburg, MD and will report to the Director, Study Management Cell Therapy.
Essential Qualifications: - 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
- Some travel may be required
Desirable Experience:- Early/late phase oncology clinical trial experience
- Experience in autologous or allogeneic therapies
- Clinical Study Management experience
#CellTherapy
The annual base pay for this position ranges from $112K to $168K. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
