Brigham and Womens Hospital - Boston, MA

posted 2 months ago

Full-time - Mid Level
Boston, MA
501-1,000 employees
Hospitals

About the position

The Project Manager at Brigham and Women's Hospital's Cardiac Imaging Core Lab (CICL) is responsible for managing all aspects of assigned clinical trials, including image receipt, data transfer, and reporting. This role involves liaising with sponsors, CROs, and clinical trial sites, ensuring efficient operations, and maintaining document control standards. The Project Manager will also support the development of training materials and oversee the technical aspects of image processing and troubleshooting.

Responsibilities

  • Manage all aspects of assigned clinical trials including image receipt and processing, data transfer, and reporting.
  • Track media received, inventory control, and ensure proper follow-up of pending project tasks.
  • Monitor project timelines and report study-specific metrics to sponsors/CROs.
  • Serve as the primary liaison with Sponsor/CRO and CICL leadership for day-to-day issues and progress reporting.
  • Represent the CICL at site Investigator Meetings and imaging-centered training sessions for site staff.
  • Maintain appropriate document control standards per MGB and CICL SOPs.
  • Process incoming subject/study documents and images for accuracy and completeness.
  • Manage distribution of technical feedback to sites and resolve CICL-generated queries.
  • Assist technical teams to prioritize timelines and ensure progress towards data transfer deadlines.
  • Report study metrics to Business Manager for invoicing and other reporting as requested.
  • Support sites with questions regarding study protocol and image submission process.
  • Lead on-site monitoring and auditing visits.

Requirements

  • BA/BS degree in biological sciences or health administration.
  • At least 5 years of experience in clinical research and/or trial project management.
  • Knowledge of FDA regulations, ICH and GCP guidelines concerning human subject research.
  • Experience with disaster recovery and regulatory compliance of research core labs.

Nice-to-haves

  • Experience in cardiovascular medicine and clinical trial project management.
  • Strong communication skills, both verbal and written.
  • Ability to work in a dynamic and busy environment.

Benefits

  • Health insurance
  • 401k
  • Paid holidays
  • Flexible scheduling
  • Professional development opportunities
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