Purpose:
The Trial Master File (TMF) Project Management Assistant at Lilly Capability Center India (LCCI) serves in a key role for the execution of TMF Operations processes and administration. Provides process support for TMF creation, maintenance, closure and archival. Provides support for TMF Operations to resolve any issues identified with the TMF activities. Works with Trial Master File (TMF) Project Management Associate, study teams and functions to help mitigate issues, identify impact to applicable internal processes and support process improvements. Executes change management oversight to ensure consistent application of revised standards, processes, and systems functionality across study teams. The TMF Project Management Assistant will ensure the TMF for the clinical trial(s) are inspection ready through a complete, accurate and readily available in the Electronic Trial Master File (eTMF). Additional country specific responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.
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.
1. TMF Expertise
· Serve as TMF subject matter expert.
· Partner with internal colleagues to create 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).
· Assists TMF Project Managers by supporting study teams with TMF related remediation and process execution inquiries.
· Assists TMF Project Managers in eTMF process related questions and answers. Provide support to ongoing and ad-hoc TMF projects and initiatives.
2. Project Management
· Support execution of TMF Functional Checks for the trial throughout the life of the trial.
· Provide support with TMF Operations administrative activities such as TMF open office hours, meetings agendas/minutes, etc.
3. Partnership
· Collaborate and influence functional representatives and record owners to ensure TMF remains complete, current and correct.
· Identify opportunities to share learning to the functions as appropriate.
· Support integration of partnered or acquired clinical information including transfer of TMFs in compliance with applicable regulations and best practices.
· Assist with eTMF configuration testing, as needed.
4. Clinical Trial Essential Document Responsibilities
· Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified
· Complete administrative tasks (e.g., status reports) as requested
· Participates in study specific training as required.
· Evaluate and tailor the expected documents (ED) to ensure proper tailoring has been assessed to make a trial specific TMF.
· Evaluate the TMF records prior to finalization, as appropriate.
· Communicate directly with functional areas for proper hands-off to occur during the start-up, maintenance, and close-out of the trial.
· Identify, communicate, and resolve issues.
· Ensure appropriate functional check oversight activities occur for all functional areas.
· Ensure appropriate archiving of clinical trial documents to meet Lilly record retention policies and regulatory requirements.
· Understand, comply, and reinforce local regulations and guidance, Lilly medical policies and procedures, and good clinical practices (GCP)
· Ensure inspection readiness through a complete, accurate and readily available Trial Master File.
· Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified.
Minimum Qualification Requirements:
§ 1-2 years’ experience with clinical development processes
§ Bachelor’s 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
§ 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:
§ 1-2 years TMF experience a plus
§ 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 policies
§ Effective communication, teamwork and problem-solving skills
§ Self-management and organizational skills