eTMF and Clinical Trial Management System (CTMS)

Milestone Pharmaceuticals•Charlotte, NC

10d

About The Position

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.

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.