Sr. Clinical Trial Associate/Clinical Trial Associate

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.
Key Responsibilities

• Provide high quality assistance in managing and overseeing Clinical Trials according to ICH GCP, and applicable regulatory requirements and SOPs
• Support PMV CTM(s) on project related activities and deliverables as required, such as:
  • Authoring/editing study documents, plans, and tools, and tracking versions (e.g. ICFs, pharmacy manual, dosing diaries, etc.)
  • Vendor oversight activities (e.g. tracking activities, collecting reports, filing documents)
  • Clinical data output, collation, and analysis activities
  • Communicating with study site personnel, CRO and other vendors, as applicable, to ensure studies progress in accordance with agreed timelines and scope
  • Coordinating project team meetings, distributing agendas, recording, and finalizing meeting minutes, and collating various presentations
  • Assisting in the management of IMP and other study related supplies, as needed
• 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
• May support contracts and budget activities (e.g. administrative activities related to invoice processing and change orders)

• Other duties and assignments as requested for the overall performance of the function and Company

Qualifications

• BA/BS degree or higher
• Minimum 2 years related experience in the pharmaceutical industry (Sponsor, Site, and CRO experience considered)
• 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

Benefits

• PMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Program, and much more.

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