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TMF Study Lead

Company: Kelly Services
Location: Allentown
Posted on: April 9, 2021

Job Description:

Kelly Services-- has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a TMF Study Lead at a prestigious Fortune 500-- company working in Lawrenceville, NJ--Important information:--This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the "Submit Resume" button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position () however your resume must be received via the "Submit Resume" button included within.--Job Title: TMF Study Lead--Pay: $42.86--per hour --Job description:Functional Area Description The centralized TMF organization is responsible for the completeness and accuracy of the Trial Master File for all 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 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 internal policies.Objective Key deliverables include monitoring and assessing the overall health of the TMF, ensuring quality, completeness and timeliness in the eTMF for all 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 environmentRequirementsMinimum of Bachelor's degree in a scientific or related disciplineAt 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----We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: .Kelly Services-- is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.Kelly Services is an Equal Opportunity Employer----Why Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, Trenton , TMF Study Lead, Other , Allentown, New Jersey

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