Job Description

“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”

Job Description: Title: TMF Study Lead

Functional Area Description The centralized TMF organization is responsible for the completeness and accuracy of the Trial Master File for all Client-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 Client-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 Client internal policies.

Position Summary / Objective Key deliverables include monitoring and assessing the overall health of the TMF, ensuring quality, completeness and timeliness in the eTMF for all Client-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.

Position Responsibilities • Monitor the adherence to ICH/GCP Guidelines, regulatory requirements and BMMS 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

Degree Requirements Minimum of Bachelor’s degree in a scientific or related discipline

Experience Requirements At least 5 years of 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 paced environment and delivering results within tight timelines is desirable

Key Competency Requirements • 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

How to Apply

Job Types: Temporary.

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