Lotus Clinical Research 100% Remote
Who we are: www.lotuscr.com
About the role:
The TMF Specialist supports Regulatory Operations by managing, reviewing, and approving site-level documentation within the electronic Trial Master File (eTMF). This role ensures timely and accurate filing of essential documents, maintains audit readiness, and contributes to overall study compliance. The TMF Specialist collaborates with internal teams and provides operational support across a variety of TMF-related tasks, helping to uphold documentation standards and regulatory expectations.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
Other duties may be assigned. Employee performs all, part, and/or any combination of the duties listed below.
- Review, process, and approve Trial Master File (TMF) documents submitted to the electronic TMF (eTMF), ensuring alignment with the electronic Investigator Site File (ISF) and study-specific filing requirements.
- Validate document quality by checking metadata accuracy, naming conventions, and version control prior to approval.
- Communicate with internal stakeholders to clarify document discrepancies and support timely resolution.
- File documents promptly to maintain a complete, inspection-ready TMF throughout the study lifecycle.
- Update and monitor the Expected Documents List (EDL) to reflect current document status in accordance with sponsor expectations and regulatory standards.
- Use designated systems and tools to manage document flow, track submissions, and flag potential quality issues; assist in retrieving outdated or missing documents as needed.
- Provide operational support to Regulatory Specialists and Senior TMF Specialists across a variety of tasks, including but not limited to the collection and preliminary review of Essential Documents.
- Participate in TMF audit preparation activities and support audit response efforts by organizing and verifying documentation.
- Contribute to TMF-related process improvement efforts and assist with department initiatives that enhance document quality and compliance.
- Respond to document-related questions from internal teams and external partners, escalating complex issues to senior staff as appropriate.
- Maintain familiarity with current Lotus CRO and Sponsor SOPs, TMF best practices, and applicable regulatory guidelines; suggest improvements to streamline TMF workflows.
- Assist with document intake and categorization from sites and vendors, ensuring accurate routing and timely processing.
- Monitor TMF completeness reports and escalate gaps or delays to senior staff for resolution.
EDUCATION and/or EXPERIENCE
- Bachelor’s degree in biological sciences or a related field preferred.
- At least 1 year of experience in clinical research, document management, or regulatory operations.
- Experience with electronic document management systems and eTMF platforms (e.g., Veeva Vault) strongly preferred.
- Familiarity with Good Clinical Practices (GCP), ICH guidelines, and the DIA TMF Reference Model is desirable.
SKILLS and/or ABILITIES
- Knowledge of regulatory requirements for clinical research, including GCP and ICH guidelines
- Knowledge of Good Clinical Practices (GCP), regulations/guidelines, auditing processes, and compliance requirements in relation to TMF
- Experience with electronic document management system(s) and eTMF with Veeva eTMF experience strongly preferred
- Working knowledge of the DIA TMF Reference Model is strongly preferred
- Strong working knowledge of procedures and guidelines in Clinical Research
- Excellent organizational and coordination skills
- Solid understanding of the process of clinical drug development
- Strong written and verbal communication skills
- Exceptional attention to detail
- Strong interpersonal skills
- Proficiency in Microsoft Office
- Effective time management and organizational skills
- Ability to handle multiple tasks simultaneously
