eTMF Specialist

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

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

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

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

Join us and build your future here.

What You'll Be Doing:

• reputed company and manage reputed company eTMF activities associated with a TMF quality review and act as the primary reputed company of contact for project teams, Sponsors, auditors, and multiple vendors as needed on assigned studies/programs.
• Author (w/ guidance) quality review documentation needed to reputed company a study's TMF quality review (site level checklists, country level template and study guidance).
• Set up, organize, and reputed company quality reviews
• Review / QC work of TMF Associate
• Author (w/ guidance) study specific eTMF Management Plans, eTMF Review and Remediation Plans.
• Activate eTMFs reputed company the selected eTMF platform, as necessary.
• reputed company and organize reputed company reputed company 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.
• reputed company quality reputed company of scanned documents, correct orientation of pages for readability, and review document completion.
• reputed company 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

reputed company Are Searching For:

• Bachelor’s degree, or international equivalent from an accredited institution, in information management, library science, clinical, science, or health reputed company field, or an equivalent combination of education and experience
• 2 – 4 of clinical trial records management experience reputed company 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

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