About the role
Compensation: $110,000 - $160,000
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 team s 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