The Senior TMF Specialist, under the guidance of Associate Manager - TMF Operations, is a functional lead for study TMF and is responsible for driving the TMF to be inspection ready by means of identifying completeness gaps in the TMF, generating and creating visibility of meaningful TMF metrics to get the project teams to complete their TMF related tasks, functionally supporting the TMF Specialist activities, and implementing the Quality framework of TMF activities on assigned studies
They are also responsible for the overall management and maintenance of essential clinical trial documents with high quality from set up through maintenance and close out of the TMF, with a strong focus on ensuring that routine TMF tasks are performed with adherence with SOPs (Project and Corporate) and ICH/GCP/TMF guidelines
This position plays a key role in managing internal and external stakeholders expectations
Responsibilities
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 Good 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 (eg, 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 (eg, 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 3+ 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
