Global Study Manager, Cell Therapy

AstraZeneca • Gaithersburg, MD

3d • $112,000 - $168,000

About The Position

We are pioneers of collaborative research and have built an unrivalled scientific community both internally and externally. Working seamlessly and inclusively, together we expedite research in some of the hardest-to-treat cancers. Have the opportunity to build a rewarding and meaningful career as part of the team committed to improving the lives of millions with cancer. 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. Accountabilities: 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.

Requirements

• Bachelor’s degree with 3+ years of experience
• Experience of working with and delivering through strategic partners and 3rd party vendors
• Excellent knowledge of ICH-GCP principles
• Clinical Study Management experience
• Team orientated
• Ability to lead, coordinate and prioritize multiple tasks and deliverables
• 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

Nice To Haves

• Early phase oncology clinical trial experience
• Experience in autologous or allogeneic therapies

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—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles
• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage in accordance with the terms of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level