Sr. Clinical Trial Associate

Reports to: Chief Development Officer 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.
How to Apply To apply, please submit your cover letter and resume to recruiting@pmvpharma.
com or apply through our Online Portal.
PLEASE, NO PHONE CALLS or AGENCIES PMV Pharmaceuticals is an Equal Opportunity Employer and all applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.