TMF Lead - Remote Clinical Trials & Compliance

Benefits: Dental insurance Health insurance Stock options plan Reports to: Reports to the VP, Clinical Operations SPI is seeking a highly experienced and organized TMF Lead to support the operational execution of our clinical research programs. As a TMF Lead, you will lead the smooth execution of clinical trials from start-up to close-out, work closely with CRA(s) and cross-functional teams to ensure our studies are conducted efficiently, on time, and in full compliance with ICH-GCP and regulatory standards. This role offers hands-on experience and a clear pathway for career growth. Key Responsibilities: Perform the following duties and responsibilities in support of SPI’s clinical research programs from start-up to close-out: clinical trial support, operational coordination, compliance and quality, communication and collaboration, and continuous improvement. The TMF Lead shall perform the foregoing duties diligently, professionally, and in accordance with applicable laws, regulations, Good Clinical Practice (GCP), E6 ICH Guidelines, and SPI’s relevant regulations and Standard Operating Procedures (SOPs) within the DIA Reference Model. From time to time, additional or incidental duties may reasonably be assigned by SPI, provided such duties are consistent with the position and scope of responsibilities. Clinical Trial Support · Assist in the coordination, implementation, and tracking of clinical trials from start-up through closeout. · Prepare, collect, review, and maintain essential regulatory and study documentation, including the Trail Master File (TMF) and within the DIA Reference Model, and associated electronic systems. · Support the preparation and submission of regulatory and ethics committee documentation as required. Operational Coordination · Provide advanced administrative and logistical support to Clinical Research Associates (CRAs) and Regulatory Manager in the conduct of clinical studies. · Coordinate the shipment and tracking of study supplies, investigational medicinal product (IMP), and related materials. · Maintain accurate and up-to-date study trackers, reports, and databases to monitor study progress, enrollment, and milestones. Compliance and Quality · Ensure that all documentation and study activities comply with applicable laws, regulations, Good Clinical Practice (GCP), E6 ICH Guidelines, and SPI’s relevant regulations and Standard Operating Procedures (SOPs). · Assist with internal and external audits, inspections, and ensure continuous TMF inspection readiness. · Conduct quality control (QC) reviews of clinical trial documents and systems to ensure data accuracy and completeness. Communication and Collaboration · Serve as liaison between internal teams, investigator sites, and external vendors to ensure efficient communication and coordination of study activities. · Support the preparation of agendas, meeting materials, and minutes for study-related meetings. · Support the creation and maintenance of study materials, including but not limited to site and CTA/ CRA training materials, regulatory document templates, study binders, study plans, study communications and presentations. Continuous Improvement · Participate in process improvement initiatives to enhance operational efficiency within Clinical Operations. · Provide guidance and mentorship to junior Clinical Trial Assistants (CTAs) and support staff as required. Qualifications: Education · Bachelor’s degree in life sciences or health-related field strongly desired. Experience · 5 – 7+ years of experience in CTA or clinical operations in pharmaceuticals, biotech, or CROs. · Strong understanding of ICH-GCP, regulatory guidelines, and clinical trials processes. · Experience supporting global, multi-center clinical studies. · Experience with eTMF and CTMS systems (e.g., DIA Reference Model). · Familiarity with audit/inspection preparation. · Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required. · Proficient in SharePoint, MS Outlook, Word, PowerPoint and Excel products. Other Requirements · Excellent attention to detail, time-management, and organizational skills to manage projects efficiently. · Excellent communication skills, both oral and written. · Ability to work both independently and collaboratively in a fast-paced environment. · Project management capabilities. · Understand implications of work and make recommendations for solutions. · Determine methods and procedures on new assignments. Identify areas for process or technology improvements with regard to tasks within the role. · Interact with Investigator sites for activities such as to collect relevant documentation and study materials as needed. · From time to time, additional or incidental duties may reasonably be assigned by SPI, provided such duties are consistent with the position and scope of responsibilities. We offer competitive salaries and an excellent benefits package. Successful incumbent will be able to grow into CRA or Clinical Research roles through structured mentorship and internal promotions, as well as play a key role in improving patient outcomes and medical innovation. Sound Pharmaceuticals, Inc is an Equal Opportunity Employer. If interested in pursuing an interview, please also email your resume to View email address on click.appcast.io. Flexible work from home options available. #J-18808-Ljbffr