Director, Clinical Systems & TMF Operations

Director, Clinical Systems & TMF Operations

A biotech company focused on rare diseases is seeking a Director, Clinical Systems & TMF Operations to lead strategy, compliance, and innovation within clinical documentation and technology.

Key Responsibilities:

• Oversee clinical systems (IRT/RTSM, eCOA/ePRO) and TMF operations to ensure compliance, efficiency, and inspection readiness.
• Develop and implement clinical technology strategies, ensuring smooth adoption and integration across teams.
• Lead TMF and records management initiatives, enhancing documentation processes and industry best practices.
• Partner cross-functionally with internal teams and vendors to optimize clinical system implementation and oversight.
• Provide leadership and mentorship, fostering a culture of continuous improvement and patient-centric practices.

Ideal Candidate:

• 10+ years in TMF and clinical systems management within a sponsor/CRO setting.
• Expertise with Veeva Vault eTMF, IRT/RTSM, and eCOA/ePRO systems.
• Strong leadership, project management, and change management experience.
• Ability to drive innovation while ensuring regulatory compliance.