The Senior TMF Specialist, TMF Operations reviews Sarepta TMF documentation prior to filing in the TMF and if issues and/or discrepancies are identified with TMF content, remediates directly with the Sarepta functional teams. Upon resolution of identified findings, the Senior TMF Specialist appropriately tracks resolution/closure via tracking mechanisms and uploads to the TMF.
The Senior TMF Specialist will complete a quality control review of documents uploaded by TMF Specialists, with a strong adherence to Standard Operating Procedures, Good Clinical Practice, Good Documentation Practice, International Council for Harmonization E6(R2), and ALCOA+ standards.
The Senior TMF Specialist is responsible for the overall quality, accuracy, appropriateness, and completeness review of study files; inclusive of active, maintenance, and closed sites/studies. The Senior cross-references when applicable and identifies issues and/or discrepancies for remediation activities with the Sarepta functional teams and/or external vendors to ensure completeness and accuracy of the study files.
This position is highly visible and interactive with Sarepta cross-functional teams and external vendors and plays a critical role in both paper and electronic TMF document management activities, by reconciling, reviewing, organizing, filing, remediating and maintaining paper and/or electronic records in accordance with TMF Operations processes and procedures.
Primary Responsibilities Include:
Collaborate cross-functionally with Sarepta functions for document coordination activities, ensuring that all internal documents necessary to provide an accurate reconstruction of the trial are identified and collected
Perform quality content reviews, comprehensive completeness reviews inclusive of cross-referencing, and filing of TMF documentation to the Sarepta TMF, per the TMF Reference Model filing structure
Ensure the Sarepta TMF is 'inspection ready' at all times and trial master file documents are filed contemporaneously in a timely manner, in accordance with metrics timelines
Ensures documents which fail quality review are effectively remediated and indicated as resolved/closed via tracking mechanisms prior to filing in the TMF
In preparation for study TMF closure, perform a close out review of study TMF and remediate findings with Sarepta functions and/or external vendors
Promote inspection-ready TMF's and perform real-time updates as information is received
Represent TMF Operations at study team meetings, participate in collaborative efforts and plays an important cross-functional role in TMF document retrieval and management
Provide support to TMF Operations during audits and/or regulatory inspections
Establish themselves as a trusted resource of accurate, up-to-date study TMF information
Liaise with Inspection Readiness Specialists to reconcile trial master file documents
Identify trends and escalate concerns to TMF Manager and/or Head of TMF Operations
Adheres to TMF SOP's, KPI's and relevant TMF process-supporting guidance's
Education and Skills Requirements:
BS/BA degree required
Minimum 4 years clinical research experience with 3 years relevant document management, quality content review, and comprehensive completeness review experience
Extensive TMF experience required, including experience in study start-up, maintenance, close-out, and performing quality control and comprehensive completeness reviews
Extensive knowledge and application of TMF Reference Model, ALCOA+ standard, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization E6(R2) guidelines
Subject matter expert level knowledge of clinical study file documents, clinical trial activities, and terminology
Must have knowledge of Core, Country, and Site level files and corresponding expected documents per level
Ability to maintain a high level of accuracy and attention to detail in fast-paced environment with shifting priorities
Approachable and builds constructive, positive, collaborative relationships
Must be proactive, self-motivated, and able to work independently with minimal supervision
Must have ability to navigate multiple electronic TMF systems and advanced proficiency in Word, Excel, and PowerPoint
Must have excellent organizational skills, exhibit professionalism, communicate effectively, have a 'can do' approach, and be a team player
Possess ability to effectively manage studies/sites residing with multiple CRO's in various locations with differing filing structures
Candidates must be authorized to work in the U.S.
Sarepta offers a competitive compensation and benefit package
Sarepta is an Equal Opportunity/Affirmative Action employer and participates in e-Verify