Director, Clinical Systems and TMF Operations

Pharmaceutical company looking for an individual that is passionate about transforming patient lives and thrive in a collaborative environment for their Director, Clinical Systems and TMF Operations position. Can be fully remote.

This role is crucial for ensuring that clinical trials run smoothly and comply with all necessary regulations. It involves a mix of strategic planning, team management, and hands-on oversight of clinical systems and documentation.

Responsibilities:

Clinical Systems & Technology:

• Lead CS+T strategy and initiatives.
• Develop business cases, implement solutions, and measure effectiveness.
• Partner with cross-functional teams for supplier selection and onboarding.
• Oversee CS+T vendors and ensure quality and timeliness.
• Manage contracting, budget activities, and system validation.
• Act as a change agent for new capabilities and processes.

TMF Operations:

• Strategize and manage TMF Operations.
• Implement innovative strategies for TMF and records management.
• Ensure TMF compliance and inspection readiness.
• Oversee quality control and develop training materials.
• Support audits and inspections.

Leadership:

• Provide strategic direction to the Clinical Systems and Documentation Management team.
• Manage recruitment, training, and performance evaluations.
• Forecast resource demand and assess team capabilities.
• Maintain collaborative relationships with cross-functional partners and vendors.

Requirements:

• Bachelor’s degree required; advanced degree preferred.
• 10+ years in TMF and/or Systems Management with a Sponsor/CRO.
• Experience managing staff and with Veeva Vault Clinical eTMF system.
• Knowledge of IRT/RTSM and eCOA/ePRO systems.
• Experience in clinical trial conduct is a plus.