Job Description

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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