Job Description

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. TMF Expertise Serve as TMF Subject matter expert. Partner with internal colleagues to develop metrics dashboard and reporting capabilities to demonstrate control of the TMF process. Support internal audits and external inspections, as appropriate (e.g. a table of contents based on the trial specific TMF Expected Document Lists (EDLs). Partner with TMF Project Managers with TMF related remediation and process execution inquiries and provide root cause analysis. Handles eTMF process related questions and answers. Provide support to ongoing and ad-hoc TMF projects and initiatives. Project Management Support execution of TMF process/workflow and implementation throughout the trial from start-up to close-out. Provide support with TMF Operations administrative activities such as TMF open office hours, meetings agendas/minutes, etc. Collaboration with global TMF functional group to maintain the inspection readiness of the trial. Partnership Collaborate, influence functional representatives, and record owners to ensure TMF remains complete, current, correct and inspection readiness. Identify opportunities to share learning to the functions as appropriate. Support integration of partnered or acquired clinical information including transfer of TMFs (Trial Master File) in compliance with applicable regulations and best practices. Support with eTMF configuration testing, as needed. Partnering with global functions with process implementation. Clinical Trial Essential Document Responsibilities Perform quality check of eTMF documents as per the ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) +++ guideline and liaise with project teams to resolve any issues identified. Evaluate and tailor the expected documents list (EDL) to ensure proper tailoring has been assessed to make a trial specific TMF and maintain the completeness check of the study at every study milestone. Evaluate the TMF records prior to finalization and support study team for study close out. Ensure appropriate archiving of clinical trial documents to meet Lilly record retention policies and regulatory requirements. Participates in study specific training as required. Communicate regularly with functional group for proper hands-off to occur during the start-up, maintenance, and close-out of the trial. Ensure appropriate functional check oversight activities occur for all functional areas. Understand, comply, and reinforce local regulations and guidance, Lilly medical policies and procedures, good clinical practices (GCP) and good documentation practices (GDP). Complete administrative tasks (e.g., status reports) as requested. Minimum Qualification Requirements: 3-8 yearsu2019 experience with clinical development processes Bacheloru2019s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development is desirable Experience in document administration Knowledge of cGCP and GDP High attention to detail Excellent organizational skills Strong written and verbal communication skills and Proficiency with MS Office/Adobe Acrobat Experience in working with electronic trial master files strongly preferred Demonstrated critical thinking capabilities with forward looking perspective and comfort with ambiguity. Other Information/Additional Preferences: 3-5 years TMF experience Experience working in clinical research / medical environment, including exposure to medical or regulatory records highly desired Ability to learn and comply with regulatory requirements and internal policiesu200B Effective communication, teamwork and problem-solving skillsu200B Self-management and organizational skillsu200B

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