- Acts as an SME on eTMF applications, TMF processes, document identification/filing and project team processes that result in TMF document generation/collection.
- Owns the TMF Plan/Index and leads the identification of expected documents by finding ways and means to stay abreast of the study events.
- Review the SoW to understand the scope of work and align TMF requirement to it.
- Delineate between in scope vs out of scope TMF activities.
- Build relationships with sponsor counterpart keeping Project Manager/Leader in loop to partner with them and provide inputs on best industry practices, especially if sponsor eTMF is used for assigned studies.
- Ensures the TMF file structure follows applicable company approved TMF configuration, regarding ICH Guidelines for Positive Clinical Practice, Good Documentation Practices and the TMF Reference Model, as required.
- Contribute to mentoring and grooming TMF Specialists TMF related competencies.
- Represents TMF Operations during internal/external/sponsor audits and manage findings through effective resolution both operationally and within the Veeva Vault.
- Contributes to SOPs (Project and Corporate), company guidelines, work instructions and templates (e.g., TMF set-up, quality management, reports and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc.) to ensure that TMF Operations tasks are performed in adherence with ICH/GCP/regulatory guidelines and best practices.
- Support implementation of features and contribute to change management related to usage of Veeva Vault eTMF system in conjunction with the Clinical Systems Manager.
- Acquires expertise in eTMF applications used for studies where sponsor eTMF is chosen as TMF repository.
- Contributes to streamlining the processes and implementing automation such as VBA macros, Robotic Process Automation (RPA), system integration, Artificial Intelligence (AI)/Machine Learning (ML).




- Perform tasks within eTMF application to maintain the lifecycle of the TMF (e.g., TMF set-up, EDL maintenance, reports and metrics, initiate/follow up/close out/perform periodic review, TMF close out/archival, etc.)

Qualifications

- Bachelors degree requited, preferably in scientific discipline.
- Incumbent typically will possess 7+ years of Clinical Operations/managing expected documents experience in TMF Operations.
- Knowledge of filing procedures and eTMF application is mandatory.
- Prior experience in maintaining the TMF inspection ready and/or identifying TMF completeness gap is mandatory.
- Experience in Veeva is highly desirable.
- Project management experience is desirable.
- Competent computer skills including ability to take on board new systems.
- Capability of managing competing priorities in a changeable environment and ability to handle stressful situations/deadlines.
- Thorough knowledge of GCP and TMF governing regulations, such as the TMF Reference Model required.
- Experience in NIH-sponsored clinical programs is a plus.
- Assertiveness, strong technical background, integrity, negotiation skills.
- Excellent organizational, planning, analytical, and problem-solving skills.
- Attention to detail required.
- Ability to build and maintain positive relationships with management, peers, and subordinates.
- Excellent verbal and written presentation, communication skills along with fluency in English are necessary.
- Highly motivated, results driven with unyielding predisposition to detail and accuracy.
- Demonstrate increasing levels of TMF responsibilities.
- Possess high degree of initiative and the ability to work independently.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Lead TMF Specialist (Karnataka)
🏢 Emmes Group
📍 Karnataka