TMF Study Lead
TMF Study Lead
JobDiva # 20-06163
JobDiva # 20-06163
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a TMF Study Lead for our client in Lawrenceville, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- 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.
- Deliverables include monitoring and assessing the overall health of the TMF, ensuring quality, completeness and timeliness in the eTMF for all heritage Client and Client-sponsored studies, working with the study teams and Clinical Trial Managers.
- Subject Matter Expert for TMF/eTMF, spans across all therapeutic areas and research phases, collaborates with cross-functional teams, TMF Contributors, TMF Content Owner, eTMF Business Operations and CRO/third party vendor during the close-out and archival cycle of the trials.
- 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.
- 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.
- Ensure all expected documents are complete and final in eTMF in collaboration with TMF Content Owner and Study team (study team serve as SME for their respective departments).
- Work proactively and prospectively with TMF Content Owner and TMF Contributors at Study, Country and Site level to ensure timely reconciliation and archiving of all Essential Documents in the TMF.
- Ensure controlled access to eTMF Archive and other TMF-related archive systems, as applicable.
- Ensure systems owners take any necessary actions aimed to protect from unauthorized changes, as relevant to the specific TMF system.
- Ensure the study documentation received by third party is complete, includes a documentation inventory list, and meet quality criteria before archiving documents.
- For documents transferred from the CRO, ensure transfer to appropriate long-term archive location.
- For any documents that have been maintained in hard copy, prepare and pack the documents for archival at the designated Client archiving vendor facility per Client procedures.
- Upon arrival of TMF Archivist, transfer paper documents to archiving vendor per Client procedures.
- Upon approval by TMF Archivist retrieve hard copy documents from the off-site archive vendor.
- Upon approval by TMF Archivist return the hard copy documents to the off-site archive vendor.
- 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.
- 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.
- 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 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 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, archival and retention polices 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
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
June Binuya | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.