The eTMF and CTMS Manager oversees clinical trial management systems and electronic trial master files to ensure data accuracy, user access, and inspection readiness. The role requires a bachelor's degree, 6+ years in clinical research, expertise in platforms (FLEX Databases preferred) and strong knowledge of global regulatory compliance.
KEY RESPONSBILITIES: - System Administration: Oversee the configuration and validation of CTMS and eTMF platforms within FLEX Databases system. Manage day-to-day operations, configuration updates, user provisioning, and user access for CTMS and eTMF platforms. Prepare and maintain documentation related to TMF/CTMS processes, procedures, and metrics.
- Quality Control & Compliance: Perform risk-based quality reviews of trial documents, ensure compliance with SOPs and ICH-GCP guidelines, and maintain continuous inspection readiness. Support regulatory inspections and audits by providing requested documents and information, as required.
- Cross-Functional Collaboration: Partner with clinical operations, IT, and quality assurance (QA) teams to resolve system issues and support user adoption.
- Vendor & Project Management: Coordinate with external vendors and Contract Research Organizations (CROs) to track milestones, metrics, and document reconciliation. Generate TMF/CTMS status reports for management review and project team meetings.
- Training & Process Improvement: Act as a subject matter expert on TMF/CTMS management. Develop training materials, standard operating procedures (SOPs), and dashboards to report study metrics to leadership.
ABOUT YOU:- Minimum of 2 years' experience with FLEX Databases systems, including CTMS and eTMF management
- Have been the primary person managing the implementation and configuration of eTMF and CTMS modules within FLEX Databases system
- Lead or key contributor to the validation of CTMS and eTMF modules within FLEX Databases system
- Bachelor's degree or equivalent
- Preferred experience with a pharma sponsor or CRO
- Must have thorough understanding of GCP and ICH regulations, and regulatory compliance
- Highly detail oriented personality with very strong organizational skills
- Demonstrated ability to identify and resolve issues and effectively manage timelines
