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