Key Responsibilities:
- Lead the development of study-specific eTMF plans for assigned clinical studies.
- Perform quality control of documents submitted to the eTMF using established acceptable criteria.
- Ensure clinical trial documentation is consistent with eTMF specifications, ICH-GCP guidelines, regulatory requirements, and applicable SOPs.
- Address eTMF questions pertaining to how documents are filed, and user questions related to the eTMF system.
- Ensure documents that fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed.
- Maintain Essential Document Lists (EDLs) on an ongoing basis.
- Monitor and identify study-specific eTMF trends and communicate to Clinical Operations and/or other functional teams as needed.
- Assist with inspection/audit-related activities (e.g., preparation, correction action plans).
- Maintain up-to-date knowledge of the TMF Reference Model, industry best practices, and regulatory requirements.
- Support Clinical Operations Lead/Clinical Operations Manager in performing CRO oversight as per agreed parameters.
- Collaborate with study team leads to lead the setup of studies, study teams, and sites in the CTMS ensuring programs are configured according to the specific study requirements.
- Manage end-user and group permission settings.
- Lead meetings to escalate trends, issues, and establish standards based on current industry standards.
- Continually assess that CTMS features are functioning properly and efficiently; track all issues and observations for future enhancement.
Qualifications:
- Minimum Bachelor’s degree in science/healthcare field required.
- 3+ years of relevant clinical research and TMF experience at a biotechnology, pharmaceutical company, or CRO required.
- Previous experience working in eTMF system software; experience in Veeva Vault CTMS & eTMF system software preferred.
- Good working knowledge of GCP and local clinical trial rules and regulations.
- Superior organizational, problem-solving, communication, strategic, interpersonal, and negotiating skills.
- Proven stable performance records over past 2-3 years.
