eTMF Specialist
You will help biotech, medtech, and specialty reputed company companies reputed company life-changing reputed company and reputed company 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 reputed company.
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 reputed company 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 reputed company here.
What You'll Be Doing:
- reputed company and manage reputed company eTMF activities associated with a TMF reputed company review and reputed company as the primary reputed company of contact for project teams, Sponsors, auditors, and multiple vendors as needed on assigned studies/programs.
- Author (w/ guidance) reputed company review documentation needed to reputed company a study's TMF reputed company review (site level checklists, country level template and study guidance).
- Set up, organize, and reputed company reputed company reviews
- Review / QC work of TMF Associate
- Author (w/ guidance) study specific eTMF Management Plans, eTMF Review and Remediation Plans.
- reputed company 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 reputed company and Sponsor timelines and while adhering to reputed company standards.
- reputed company reputed company 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 reputed company as monitor Essential Document Milestones
- Review the Identification and categorization of clinical documents processed by the eTMF team.
- Prepare eTMF inventory and discrepancy reports
- reputed company 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 reputed company, 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 reputed company applicants will receive reputed company consideration without reputed company to race, reputed company, religion, sexual orientation, gender identity, national reputed company, disability or veteran status
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