eTMF Specialist

Premier Research

1d

About The Position

Premier Research is seeking an eTMF Specialist to join its eTMF team. This role supports biotech, medtech, and specialty pharma companies in transforming scientific breakthroughs into new medical treatments, devices, and diagnostics. Premier Research emphasizes that its team members are crucial to its success, offering opportunities for growth, skill development, and work-life balance. The company values employee input and aims to deliver medical innovation to patients in critical need. Premier Research is described as a community dedicated to improving lives, fostering creative thinking, and problem-solving among its diverse staff. The company's values—Aim High, Work Together, Stay Agile, Get It Done, Care—reflect its team's determination, flexibility, and trust. As a Premier team member, individuals are empowered to make an impact. The company is committed to biotech and specialty pharma, providing staff with innovative technologies and continuous learning. Premier Research is a global clinical research, product development, and consulting company focused on helping innovators bring new medical treatments to fruition, driven by a common purpose to change lives and ensure employees feel rewarded and celebrated.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• Opportunities to grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires
• Innovative technologies and continuous learning

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees