eTMF Specialist

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll Be Doing:

• Lead and manage all eTMF activities associated with a TMF quality review and act as the primary point of contact for project teams, Sponsors, auditors, and multiple vendors as needed on assigned studies/programs.
• Author (w/ guidance) quality review documentation needed to perform a study's TMF quality review (site level checklists, country level template and study guidance).
• Set up, organize, and perform quality reviews
• Review / QC work of TMF Associate
• Author (w/ guidance) study specific eTMF Management Plans, eTMF Review and Remediation Plans.
• Activate eTMFs via the selected eTMF platform, as necessary.
• Lead and organize all close out activities associated with the eTMF review in conjunction with the study timelines.
• Ensure eTMF records are managed according to study Trial Master File Plan (TMFP), TMF Index and Sponsor timelines and while adhering to quality standards.
• Perform quality check of scanned documents, correct orientation of pages for readability, and review document completion.
• Oversee the transfer of electronic documents to currently utilized document management system (as required by Sponsor)
• Review eTMF content and identify required relational documents, as well as monitor Essential Document Milestones
• Review the Identification and categorization of clinical documents processed by the eTMF team.
• Prepare eTMF inventory and discrepancy reports
• Provide ongoing training in document management process, document identification and categorization, and eTMF System functionality to RPI eTMF team members, Sponsors, CROs, and vendors
• Delegate tasks to eTMF Associate as appropriate to support their billable activities
• Ensure any out-of-scope activities are reported to the Director, eTMF Service and/or department management
• Review and update internal processes to ensure efficiency and productivity may include working manual, checklists, and other reference material

What We Are Searching For:

• Bachelor’s degree, or international equivalent from an accredited institution, in information management, library science, clinical, science, or health related field, or an equivalent combination of education and experience
• 2 – 4 of clinical trial records management experience within the pharmaceutical or biotech industry
• Previous clinical trials records management experience is required
• Previous experience using computerized clinical trials records management technologies is required
• Global clinical trials experience is preferred
• Clinical trials support or pharmaceutical/medical device industry experience is preferred
• Knowledge of web-based communication tools for conferences and any other IT systems required for the job is preferred

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status