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TMF Study Lead

Company: Aerotek
Location: Princeton
Posted on: April 9, 2021

Job Description:

Description: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 client 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 policiesExperience Requirements

  • Degree Requirements Minimum of Bachelors degree in a scientific or related discipline
  • 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 desirableKey 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 About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Trenton , TMF Study Lead, Other , Princeton, New Jersey

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