Relay Therapeutics - Cambridge, MA

posted 28 days ago

Full-time - Mid Level
Cambridge, MA
Professional, Scientific, and Technical Services

About the position

As an Associate Clinical Project Manager at Relay Therapeutics, you will play a crucial role in supporting clinical studies aimed at revolutionizing the biopharma industry through innovative study design and execution. You will be an integral part of the Clinical Development Team, contributing to the successful execution of clinical studies that translate Relay's cutting-edge science into effective medicines for patients. Your responsibilities will encompass overseeing day-to-day operations, ensuring compliance, managing vendor relationships, and maintaining high-quality data throughout the clinical trial process.

Responsibilities

  • Support the day-to-day operations of clinical study execution, focusing on site oversight from startup to closeout.
  • Monitor study participant enrollment, compliance, and data flow from clinical sites, CROs, and vendors.
  • Collaborate with cross-functional teams to ensure clinical studies are delivered on time and within budget.
  • Develop and maintain strong relationships with investigators, clinical site staff, and vendors globally.
  • Manage reports to communicate study progress and key metrics to Senior Management and program teams.
  • Contribute to or author key study documents including protocols, informed consent forms, and clinical study reports.
  • Serve as the primary point of contact for contracted CROs and vendors, ensuring effective vendor management.
  • Review monitoring reports and clinical data listings to ensure reliable quality data delivery.
  • Coordinate with CROs on site selection, IRB/EC submissions, and site initiation and close-out planning.
  • Ensure compliance with regulatory and ICH GCP quality standards by maintaining clinical trial master files (TMF).
  • Assist with the onboarding and mentoring of new or junior clinical operations associates.

Requirements

  • 5+ years of experience in clinical study management, preferably with sponsor experience.
  • Strong knowledge of global regulatory and compliance requirements including US CFR, EU CTD, and ICH GCP.
  • Experience in executing clinical studies across various phases, with a preference for oncology drug development.
  • Proven track record of success in facilitating study execution and maintaining data integrity.
  • Experience in CRO, vendor, and laboratory oversight.
  • Excellent communication and public speaking skills, with strong interpersonal and organizational abilities.

Nice-to-haves

  • Experience in oncology drug development is preferred.
  • Creative problem-solving skills and the ability to manage multiple projects effectively.

Benefits

  • Competitive salary
  • Opportunities for professional development
  • Collaborative work environment
  • Health and wellness programs
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