Company: Confidential
Job Title: Senior TMF Specialist (contract)
Job Number: 87229
Location: Remote, US
Job Description
The Senior TMF Specialist will be tasked with the collection, review, maintenance, and archiving of essential regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), regulatory guidance documents, regulations and Standard Operating Procedures (SOPs). The role involves providing support to TMF content owners across various clinical programs and collaborating closely with Study Management Teams (SMTs) to ensure the TMF is current and ready for inspection.
Responsibilities
* Collaborate closely with TMF Content Owners to identify issues, conduct completeness checks, and upload documents to the electronic TMF (eTMF). * Serve as the TMF subject matter expert (SME) and primary point of contact for study teams and TMF stakeholders. * Review and categorize documents gathered from both internal and external sources. * Reconcile critical documents to prevent duplication. * Assist study teams in the TMF quality review process. * Perform quality control (QC) and maintain the eTMF for assigned studies. * Conduct data entry and reconciliation across various clinical systems and tracking tools. * Contribute to the revision of TMF-related Work Instructions and SOPs. * Support the management and oversight of study-specific trial master files. * Facilitate the transfer of study-specific trial master files from the CRO. * Follow up on quality findings and implement necessary actions. * Manage the filing process for paper documents, including QC reviews and electronic filing. * Participate in audit preparations, inspection readiness activities, and inspections as required. * Work collaboratively with internal departments and external resources to address gaps in the eTMF. * May provide training and mentoring for new and existing staff. * Develop metrics, reports, and tools/trainings related to the TMF. * Act as a stand-in to lead team meetings and manage team tasks as necessary. * Position may require occasional travel.
Required Skills
* Bachelor’s or Associate’s degree with a minimum of 4–6 years of professional experience in clinical trials, or a high school diploma with at least 6 years of clinical support experience related to essential regulatory documents. * Proven experience or understanding of the clinical research process with sponsors or CROs. * Solid knowledge of the Clinical Study Process and familiarity with relevant procedures. * Preferred familiarity with international clinical trials, clinical trial documents, and the document quality control process. * Experience with electronic trial master file systems, including uploading, reviewing, conducting quality checks, and approving required study documents. * Working knowledge of the DIA reference model. * Operates under general supervision and collaborates with the manager to set priorities and timelines. * Strong computer skills, particularly in MS Office, and experience with data/document management systems. * Ability to work efficiently, prioritize tasks effectively, and maintain attention to detail. * Excellent communication and interpersonal skills. * Strong time management abilities, exceptional attention to detail, and capability to multitask in a high-volume environment. * Team-oriented and adaptable, while upholding integrity and high ethical standards. * Ability to build strong relationships with colleagues from diverse backgrounds and areas of expertise. * Capable of performing at a high level in a team environment, whether contributing as a group member or working independently.
Application Deadline: 2024-12-09
To apply for this job please visit jobrxiv.org.