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Sr. / Clinical Trial Associate

PMV Pharmaceuticals Inc
Princeton, NJ Full Time
POSTED ON 2/13/2025
AVAILABLE BEFORE 5/11/2025

Title / Position : Sr. / Clinical Trial Associate

Job Description : The Sr. / Clinical Trial Associate is a key Clinical Operations support role which ensures delegated components of clinical trials are executed to expected and specified quality standards. The Sr. / CTA is responsible for supporting the Clinical Trial Manager (CTM), or equivalent, in managing the day-to-day Clinical Operations functional activities associated with the execution of a clinical trial, and may include managing activities in various regions, supporting the management of Clinical Research Organizations (CROs), other third-party vendors, and other study supporting activities. CTA or Sr. CTA designation will be based on breadth, depth, and duration of experience.

Key Responsibilities

Operational Execution and Oversight

  • Support PMV CTM(s) on project related activities and deliverables by providing high quality assistance in managing and overseeing clinical trials
  • Authoring / editing study documents, plans, and tools, and tracking versions such as ICFs, study plans and manuals, dosing diaries, etc.
  • Clinical data output, collation, and analysis activities
  • Assisting in the management of IMP and / or other study related supplies, as needed

Vendor / Stakeholder Management

  • Vendor oversight activities including but not limited to tracking activities (e.g. via KPIs), report collection, document filing
  • May support contracts and budget activities such as administrative activities related to invoice processing and change orders
  • Communicating with study site personnel, CRO, and other vendors, as applicable, to ensure studies progress in accordance with agreed timelines and scope

    • Collaboration

    Coordinating project team meetings, distributing agendas, recording, and finalizing meeting minutes, and collating various presentations

  • Provides regular study updates to the appropriate internal stakeholders

    • Compliance

    Perform responsibilities in accordance with ICH GCP, and applicable regulatory requirements and SOPs

  • Set-up and management of the Trial Master File (TMF) for assigned study / studies, as appropriate. Candidate must have a deep understanding of the processes for set-up, maintenance, QC, and close-out of the TMF, and ability to teach more junior staff how to be in line with ICH / GCP and the importance of having an inspection ready TMF at all times
  • Supporting audit / inspection readiness by collaborating with relevant external vendors and clinical sites to prepare for and respond to audit / inspection findings conducted by internal QA and external regulatory agencies as applicable

    • Other duties and assignments may be assigned for the overall performance of the function and Company.

    Qualifications

  • BA / BS degree or higher
  • 1-2 years related experience in the pharmaceutical industry (Sponsor, Site, and CRO experience considered) for CTA and 2 years related experience for Sr. CTA
  • Possess a general understanding of clinical trials, the drug development process, and ICH GCP regulations
  • Strong attention to detail and meticulous follow-through and can be relied on in team or individual situations to deliver on deadline and scope commitments
  • Ability to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures in a fast-paced environment
  • Proficiency using MS Office applications
  • Exceptional oral, written, and interpersonal skills

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