The Manager, Records Management
will provide support for TMF activities
by ensuring documents uploaded to the TMF adhere to Standard Operating Procedures, ICH GCP
guidelines
and other regulatory requirements.
The Manager will act as a TMF Subject Matter Expert (SME) and work with the study teams to ensure the TMFs and CTMS for clinical studies are inspection ready at all times.
Essential Duties and Responsibilities
- Review study documents received from the study teams for completeness and accuracy and upload to the Trial Master File (TMF)
- Perform quality control of documents submitted to the TMF per SOPs, Work Instructions and Guidance Documents.
- Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed.
- Perform TMF quality reviews to ensure completeness, accuracy and timeliness of study documents to ensure TMFs are inspection ready at all times.
- Provide feedback, support and training to study teams to build knowledge and awareness of good, quality documentation management practices for clinical trials.
- Conduct TMF educational workshops/training, as needed.
- Address TMF questions pertaining to how documents are filed, and user questions related to the TMF system.
- Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis.
- Perform the secondary review of site Essential Document Packages per applicable SOPs to ensure sites meet the requirements for site activation and Investigational Product (IP) release.
- Responsible for Clinical Trial Management System (CTMS) maintenance, including study, country and site level updates and reviewing CTMS entries for accuracy.
- Contribute to TMF QC Tools as needed to match with evolving business processes (incl. QC Tool, QC Manual, Doc Owner Manual, TMF Newsletters).
- Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory considerations as applicable to the job duties.
- Assist with inspection/audit related activities (e.g., preparation, corrective action plans).
- Execute other duties as assigned.
Qualifications
- Minimum 2 years of relevant clinical research and TMF experience required
- Understanding of the clinical trial process, experience in handling clinical trial related documents required
- Previous experience in electronic TMFs, Veeva preferred
- Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management
- Must be self-motivated, well-organized, detail-oriented, and have excellent written and verbal communication skills
- Demonstrated ability to achieve high performance goals and meet deadlines in a fast- paced environment
- Strong organization skills with outstanding attention to detail and follow-through
- Must be highly resourceful and adaptable to effectively support multiple competing demands and changing priorities
- Demonstrated proactive approaches to problem-solving with strong decision-making capabilities
- Must be fully proficient in MS Office Suite and internet research
