TMF Manager – Temporary


Temporary

Framingham, MA

Responsible as an In-House Trial Master File (TMF/eTMF) Manager for all BERG Clinical Research Trials, in human participants. These responsibilities may function independently of each other, or combined, as necessary.

Responsibilities

  • Oversees clinical monitoring activities outsourced to CRO/or contract CRAs; Co-monitors or performs sponsor visits to the study sites with the assigned CRAs as required; Reviews, comments & documents monitoring visit report reviews and escalates issues to clinical operations project lead as appropriate.
  • Creates & maintains study-specific tracking tools and project files as needed.
  • Assists in the preparation of the site and in-house Sponsor inspections.
  • Manages clinical documents and ensures documents are current, and “inspection ready”, at all times.
  • Effectively communicates with study team members and works closely to address challenges.
  • Represent Clinical Operations at study team meetings and participate in collaborative efforts.
  • Participates in the set-up of the clinical database (UAT testing).
  • Helps to identify, create and establish study tools for the department.
  • Consistently performs duties within established Standard Operating Procedures, and in accordance with Good Clinical Practices.
  • Performs verification and quality control of essential regulatory documents and is well versed in the organization of a Trial Master File (TMF)/electronic Trial Master File (eTMF).
  • Manages the eTMF systems and ensures TMF Inspection Readiness is current, and “inspection ready”, at all times.
  • Responsible for scanning, organizing, and uploading documents to the eTMF.
  • Responsible for ensuring the TMF is complete, contemporaneous, and quality ensured.
  • Manages TMF projects and performs a risk-based review of TMF activities being performed by Clinical Operations and external vendors.
  • Ensures key performance indicators (KPIs)are met.
  • Manage TMF projects, assist with overall change management, and build collaborative relationships with cross-functional teams.
  • Provide support to Clinical Operations during eTMF implementation, audits, and/or regulatory inspections.
  • Ensure functional compliance with TMF/eTMF SOP’s, relevant TMF/eTMF process-supporting guidance’s and applicable global regulations.
  • Perform risk-based quality content reviews and monitor internal/external KPIs.
  • Represent TMF/eTMF Operations at study team meetings, participate in collaborative efforts and play an important cross-functional role in TMF/eTMF document retrieval and management.
  • Ensure documents which fail TMF/eTMF quality content and/or TMF/eTMF inspection readiness review are effectively remediated by internal/external representatives.
  • Monitor and identify study-specific TMF/eTMF trends and escalate concerns to the Head of Clinical Operations.
  • Coordinate the long-term storage archival of original documents and maintain document integrity, per mandatory retention policies.
  • Other duties as assigned.

Qualifications

  • 7+ years of clinical research experience with four (4) years of relevant document management, vendor oversight, quality content review, and comprehensive completeness review experience.
  • Bachelor’s Degree is preferred
  • Extensive knowledge of Human Anatomy & Physiology, Medical Terminology, Medical Abbreviations, and onsite Clinical Practice.
  • Extensive knowledge and application of Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization E6(R2) guidelines. Must be knowledgeable in domestic and global regulatory requirements and guidance.
  • Extensive TMF/eTMF experience required, including experience in study start-up, maintenance, close-out, and performing quality control and comprehensive completeness reviews.
  • Subject matter expert level knowledge of clinical study files documents, TMF Reference Model, clinical trial activities, and terminology.
  • Must have knowledge of Core, Country, Site files, and level-specific expected documents.
  • Ability to lead day-to-day support of study operations, including tracking and creating overviews of the subject, site, study status, milestones, and performing quality check activities across components of the clinical study and in conjunction with the CRO and other project-associated vendors.
  • Must have the ability to manage and navigate multiple electronic TMF/eTMF systems and advanced proficiency in Word, Excel, and PowerPoint.
  • Ability to navigate EDC systems and review data as needed to meet project objectives.
  • Ability to maintain a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities.
  • Approachable and builds constructive, positive, and collaborative relationships with key internal stakeholders and external vendors.
  • Must be proactive, self-motivated, excel at relationship building, and able to work independently with minimal supervision.
  • Must have excellent organizational skills, exhibit professionalism, integrity, communicate effectively, have a “can-do” approach, advanced problem-solving skills, and be a team player.
  • Participate in TMF/eTMF educational workshops and training.
  • Travel up to 20% domestically or globally.

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