Senior Trial Master File Specialist, TMF Operations

Sarepta Therapeutics Cambridge , MA 02138

Posted 2 months ago

The Position:

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

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Senior Trial Master File Specialist, TMF Operations

Sarepta Therapeutics