What are the responsibilities and job description for the Sr. / Clinical Trial Associate position at pmvpharma?
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
Vendor/Stakeholder Management
Collaboration
Qualifications
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
- 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
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
Salary : $115,000 - $150,000
