TMF Operations Associate I

The TMF Operations Associate is responsible for providing support to TMF Operations in processing, maintaining, and archiving of all essential documents in compliance with the relevant Standard Operating Procedures, study plans, country regulations and industry best practices The TMF Operations Associate will be responsible for tracking, document maintenance, as applicable, supporting the oversight of electronic Trial Master File (eTMF) and TMF Operations activities. The TMF Operations Associate will be working closely with the TMF Specialists, Business Operations & Analytics, and cross-functional teams to ensure that clinical eTMFs are inspection readied and in compliance with SOPs, ICH/GCP/regulatory guidelines, company values and goals.

Tasks may include but are not limited to: Perform all QC related tasks in the Veeva Vault eTMF System, including document QC Review, classification, and approval of essential documents. Maintenance and management of overall documents in the Veeva Vault eTMF system, including coding and filing of all study documents per DIA model structure Review hard copy documents and scan documents according to SOPs, WIs, and other governance documents. Ensure document quality and compliance through active engagement with clinical study teams and management Support TMF Specialist(s) during periodic file review for all clinical studies and prepare any supporting QC Review materials, as needed, for study teams. Escalate any TMF Quality issues in a timely manner to relevant stakeholders. Generate reports to provide to study teams and relevant stakeholders to highlight QC Review issues, user access etc., Support processing of user access requests for Veeva Vault eTMF Prepare for and complete all required activities for archival of TMF Content in compliance with the relevant Standard Operating Procedures, study plans, country regulations and industry best practices. All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs Support process improvement initiatives, as needed.

Bachelor’s degree or equivalent or combination of relevant experience and training New to industry or up to 2 years of progressively relevant experience in a pharmaceutical, biotechnology or related environment in roles focused on clinical trial documentation. Working knowledge of the Drug Information Association (DIA) Trial Master File Reference model and a demonstrated understanding of records management best practices Working knowledge of ICH E6 Section 8 Essential Documents and Good Documentation practices (GDP; ALCOA) Veeva Vault Experience highly preferred Prior experience with international studies and review of relevant regulatory documents is highly desirable. Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members Display strong interpersonal skills in a fast-paced, deadline-oriented, rapidly changing environment Possess excellent written and verbal communication skills to clearly and concisely present information Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines Exercise sound judgment and ability to identify decisions requiring supervisory approval Demonstrate proficiency in Microsoft Word and Excel Excellent planning, organization, and time management skills, including the ability to support and prioritize multiple projects Demonstrated understanding of the clinical drug development process and clinical trial methodology