TMF Study Lead
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
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The centralized TMF organization is responsible for the completeness and accuracy of the Trial Master File for all BMS-sponsored studies. The group will deliver technical expertise in the Trial Master File (paper TMF & electronic TMF) management and will provide support for the book of work for all BMS-sponsored clinical trials throughout the lifecycle of the trial. The group will support inspection readiness goals in compliance with ICH/GCP Guidelines, regulatory requirements and BMS internal policies.
Key deliverables include monitoring and assessing the overall health of the TMF, ensuring quality, completeness and timeliness in the eTMF for all BMS-sponsored studies, working with the study teams and Protocol Managers. Subject Matter Expert for TMF/eTMF, spans across all therapeutic areas and research phases, collaborates with cross-functional, global clinical research studies throughout the lifecycle of the trials.
Monitor the adherence to ICH/GCP Guidelines, regulatory requirements and BMS policies as it relates to the completeness and accuracy of the TMF at the study level by ensuring the required documents reside in the TMF as per the Study-Specific Master Plan and Master List and are inspection ready at all times.
Work with study team to define the TMF Plan and to build the Study Master list from the Toolkit - TMF Master List
Define expected documents for the study and maintain appropriate placeholder or Expected Document Lists in the eTMF system in collaboration with Study team (study team serve as SME for their respective departments)
Work proactively and prospectively with TMF Contributors at Study, Country and Site level to ensure timely uploading of all Essential Documents in the TMF
Periodically perform risk-based quality reviews of the TMF content by utilizing metrics and reports to assess any missing documents and then following-up with the appropriate functional group or document owner to mitigate, as per established review schedule
Resolve noncompliance with overdue quality review findings and overdue "In-Progress" eTMF documents, which will improve the accuracy of the TMF
Monitor and identify TMF trends and escalate concerns to management
Generate, organize, and deliver on TMF performance metrics at the site, study, country and compound levels.
At study completion, ensure the TMF is ready to be archived
Coordinate the long-term storage archival of original documents and maintain document integrity per retention policies
Manage complex export requests for Health Authorities and divestitures and independently solve technical issues
Leverage interpersonal and influencing skills to foster partnerships across multidisciplinary teams
Assist in overall change management and build collaborative relationships with cross-functional team and third party vendors
Participate in reviewing and updating documents to ensure that they are reflective of industry standards, applicable regulations and are easily retrieved following a regulatory inspection
Exhibit good project management skills that include working closely with the study teams to achieve goals and meet success criteria within specified timelines
Display good time management skills, the ability to produce deliverables efficiently, meet timelines, and prioritize workload to meet business goals.
Provide support to TMF implementation, internal audits and regulatory inspections
Demonstrate ability to make decisions, deliver on commitments, share knowledge, acknowledge others achievements, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment
Minimum of Bachelor's degree in a scientific or related discipline.
At least 5 years of pharmaceutical industry or drug development experience required.
At least 3 years TMF experience required, including experience in study start-up, maintenance and closeout, and performing quality and completeness reviews.
Relevant experience in clinical trials related roles (i.e. clinical operations and project management). Previous experience with independently managing projects and handling concurrent tasks in a fast pace environment and delivering results within tight timelines is desirable.
Extensive knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices and International Council for Harmonization guidelines (E6(R2))
Subject Matter Expert knowledge of clinical trial documentation, TMF Reference Model, clinical trial activities and related terminology
Must have knowledge of Core, Country and Site level essential documents
Must have ability to navigate eTMF system and show advance proficiency with Window Office tools
Critical thinker: Utilizing an intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing and/or evaluating information gathered from, or generated by, experience, reasoning or communication that will be instrumental in the decision-making process for quality review
Very strong communication and interpersonal skills, verbal and written, is required
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.