Manager eTMF and Clinical Trial Management System (CTMS)

• 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.

• 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

EEOC STATEMENT: Milestone believes in a diverse environment and is committed to equal employment opportunities for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Milestone will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.