Clinical Trial Manager Jobs

About The Position

Requirements

• Bachelor's degree or equivalent
• 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
• 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

Nice To Haves

• Preferred experience with a pharma sponsor or CRO

Responsibilities

• 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.
• 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.
• Partner with clinical operations, IT, and quality assurance (QA) teams to resolve system issues and support user adoption.
• 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.
• 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.