Associate Clinical Project Manager

Role Summary

Associate Clinical Project Manager responsible for supporting clinical studies that advance speed and quality of study design and execution. An integrated member of the Relay Tx Clinical Development Team contributing to the execution of clinical studies translating Relay’s science into medicines for patients.

Responsibilities

• Support the day-to-day operations of study execution, with a focus on site oversight from study startup to study closeout, study participant enrollment, monitoring, compliance, and data flow and metrics from the clinical sites, CROs and vendors.
• Collaborate with a dynamic Relay cross-functional team to deliver clinical studies that are on time and within budget guidelines, while 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, but not limited to, 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:
  • serving as primary point of contact for contracted CROs and vendors
  • identifying potential risks and proactively resolving issues with CROs and vendors
  • ensuring vendor contracts meet requirements and are efficiently executed with key performance indicators
  • partnering with the vendor to ensure accurate budgeting and accrual of costs throughout duration of each clinical study
• You will ensure reliable quality data are delivered by reviewing monitoring reports, protocol deviations, clinical data listings and performing or overseeing site monitoring visits, as needed.
• You will develop action plans to address protocol compliance, safety, data and administrative issues with clinical sites and CROs.
• You will coordinate with CROs on site selection, IRB/EC submissions, site initiation and close-out planning.
• You will provide oversight and ensure maintenance of clinical trial master files (TMF) to ensure compliance with required regulatory and ICH GCP quality standards and consistency with SOPs.
• You will partner with the CRO to lead, plan, and execute clinical Investigator meetings study meetings, as needed.
• You and your team will participate in preparation of regulatory filings (e.g. IND, NDA, orphan drug applications etc.) as needed.
• You will 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.
• You will assist with the 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 success to facilitate study execution, accelerate timelines, maintain data integrity, and satisfy health authority requirements.
• Experience in executing clinical studies across various phases is desirable; oncology drug development is preferred.
• Strong and current knowledge of global regulatory and compliance requirements including US CFR, EU CTD, and ICH GCP applicable to the conduct of clinical trials.
• Experience in CRO, vendor and laboratory oversight.
• You are a motivated self-starter who is capable of flourishing 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.

Skills

• Project management
• Communication
• Public speaking
• Interpersonal skills
• Organizational skills
• Attention to detail
• Creative problem-solving