Clinical TMF Operations Administrator

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead Trial Master File (TMF) activities for designated clinical trials throughout the start-up, maintenance, close-out, and archiving phases, ensuring effective communication with Clinical Trial Teams (CTT) and Contract Research Organization (CRO) partners.

• Supervise the establishment and upkeep of processes for cataloging, filing, retrieval, storage, preservation, and safeguarding of TMF records (both electronic and paper) and Clinical Trial Management System (CTMS) outputs.

• Oversee eTMF integrity by managing Quality Issue (QI) workflows, ensuring timely resolution of quality control/quality review (QC/QR) findings, including appropriate closure or reassignment of QIs.

• Administer Expected Document Lists (EDL), ensuring completeness, accuracy, and reconciliation of document counts in collaboration with CTT and CRO teams.

• Monitor adherence to TMF business processes and escalate any risks or instances of non-compliance to Clinical Operations and Quality leadership as required.

• Provide scheduled and ad hoc TMF health metrics, analyses, and insights to assist trial teams and leadership in decision-making.

• Ensure TMF readiness for inspections through ongoing quality oversight, including ad hoc QC reviews of uploaded documents and adherence to filing/naming conventions in line with the TMF Reference Model.

• Offer subject matter expertise (SME) during audits and inspections, encompassing preparation, support, and remediation activities.

• Keep abreast of regulatory requirements, TMF Reference Model standards, and industry best practices.

• Assist with TMF document processing, including oversight of filing, troubleshooting, and addressing TMF-related inquiries.

• Participate in trial-specific and departmental meetings, offering TMF expertise and status updates.

• Conduct general operational and administrative tasks to support assigned trials.

• Contribute to TMF strategy, planning, and continuous improvement initiatives, including the development of processes, tools, and training for TMF stakeholders.

• Support Clinical Operations leadership on impactful projects and organizational initiatives.

• Oversee TMF operations, proactively identifying risks, anticipating challenges, and implementing mitigation strategies to ensure the achievement of team and project objectives.

⛳️ Requirements

• A bachelor's degree in a relevant field and 4+ years of professional experience, preferably in a clinical research context.

• 2-3+ years of experience in eTMF document management (either within a specialized team or as part of a clinical trial team) is advantageous.

• Strong organizational and prioritization skills to manage workload effectively and maintain attention to detail.

• Significant experience collaborating with the DIA (CDISC) TMF Reference Model.

• In-depth knowledge of FDA regulations, ICH guidelines, and Good Clinical Practice (GCP).

• Experience leading or managing TMF operations, including cross-functional collaboration with Clinical Trial Teams, CROs, and vendors.

• Ability to influence stakeholders, appropriately escalate risks, and foster accountability across teams.

• Experience in generating and interpreting TMF health metrics and analytics to guide decision-making and enhance performance.

• Proven track record in process improvement, Standard Operating Procedure (SOP) development, and TMF strategy implementation.

• Excellent organizational and prioritization capabilities with a keen attention to detail.

• Proactive, solution-focused mindset with the ability to foresee risks and apply mitigation strategies.

• Strong communication skills, capable of presenting insights and recommendations to both operational teams and leadership.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Life insurance.

• Disability insurance.

• 401(k) savings plan.

• Flexible spending accounts.

• Employee assistance program.

• Tuition reimbursement program.

• Voluntary benefits including group legal, critical illness, identity theft protection, pet insurance, and auto/home insurance.

• Sick time policy.

• Flexible vacation policy.

• Parental leave policy.