Clinical Project Manager

Overview

As Clinical Project Manager, you will be accountable for managing clinical studies that will lead the biopharma industry in speed and quality of clinical study design and execution. You will be an integrated member of the Relay Tx scientific team, responsible for the execution of clinical studies that will translate Relay’s innovative science into impactful medicines for patients.

Responsibilities
:

• Oversee day‑to‑day operations of study execution, focusing on site oversight from study startup to closeout, patient enrollment, monitoring, compliance, and data flow and metrics from clinical sites, CROs, and vendors.
• Collaborate with a dynamic Relay cross‑functional team to deliver clinical studies on time and within budget guidelines, ensuring quality in accordance with the protocol and ICH GCP guidelines.
• Develop and maintain strong relationships with investigators, clinical site staff, and vendors globally, with the capability of understanding and explaining complex scientific topics to these stakeholders.
• Manage reports for communicating study progress and key metrics to Senior Management and program teams.
• Contribute to or author key study documents including protocols, informed consent forms, case report forms, study governance committee charters (e.g., data monitoring committee), study plans and clinical study reports.
• Accountable for effective vendor management by acting as primary point of contact for contracted CROs and vendors; identifying potential risks and proactively resolving issues; ensuring vendor contracts meet requirements and are efficiently executed with key performance indicators; partnering with vendors to ensure accurate budgeting and accrual of costs throughout each clinical study.
• Ensure reliable quality data are delivered by reviewing monitoring reports, protocol deviations, clinical data listings and performing or overseeing site monitoring visits, as needed.
• Develop action plans to address protocol compliance, safety, data and administrative issues with clinical sites and CROs.
• Coordinate with CROs on site selection, IRB/EC submissions, site initiation and close‑out planning.
• Provide oversight and ensure maintenance of clinical trial master files (TMF) to ensure compliance with regulatory and ICH GCP quality standards and consistency with SOPs.
• Partner with CRO to lead, plan, and execute clinical investigator meetings and study meetings, as needed.
• Participate in preparation of regulatory filings (e.g., IND, NDA, orphan drug applications) as needed.
• Ensure inspection readiness by collaborating with CROs and providing support to clinical sites to prepare for and respond to audit/inspection findings conducted by internal QA and external regulatory agencies.
• Assist with onboarding and mentoring of new or junior clinical operations associates.

Qualifications
:

• 5+ years of experience in clinical study management; sponsor experience strongly preferred.
• Recognized as a clinical operations expert with a track record of facilitating study execution, accelerating timelines, maintaining data integrity, and satisfying health authority requirements.
• Experience in executing clinical studies across various phases desirable; expertise in oncology drug development preferred.
• Strong knowledge of global regulatory and compliance requirements including US CFR, EU CTD, and ICH GCP applicable to clinical trials.
• Experience in CRO, vendor, and laboratory oversight.
• Motivated self‑starter capable of thriving in a fast‑paced small company environment.
• Creative problem‑solver with excellent communication and public speaking skills.
• Strong interpersonal and organizational skills, with a high degree of attention to detail.
• Pragmatic and able to manage multiple projects and needs effectively.

Estimated Salary Range
: [$102,000 - $145,000].

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