Associate Director, TMF Operations
Core
Oversees TMF and document management services, ensuring effective delivery, quality control, and adherence to regulatory standards for clinical trials.
Role type
Senior management IC (TMF Operations)
Builds
TMF and document management services for drug development and commercialization
Domain
Life sciences / Clinical Operations
Required skills
TMF Operations, Clinical Operations, Clinical Document Management, eTMF systems (Veeva Vault), Resource planning, Capacity management, Operational delivery, GCP, Regulatory requirements, TMF quality standards
Preferred skills
CRO, Pharmaceutical, Biotechnology environment experience
Technologies
Veeva Vault
Responsibilities
Oversees salary administration, interviewing, selection, employee development, performance management, and job description preparation. Provides guidance to staff and managers on administrative policies, operational priorities, and departmental procedures. Facilitates cross-functional processes, resource planning, and communication across departments. Plans and negotiates resource allocation with functional leaders. Serves as a key escalation point for internal and external stakeholders. Supports management in preparing, reviewing, approving, and presenting information during project and departmental review meetings. Develops and implements training programs to enhance team capability and performance. Supports project financial management activities, budgeting, forecasting, and process improvement initiatives. Facilitates project reviews with Clinical Operations teams, focusing on budget, timelines, resource utilization, and risk management. Collects, analyzes, and reports operational metrics to senior leadership. Leads the development, review, and implementation of SOPs and Work Instructions. Establishes and monitors operational metrics, KPIs, and cycle times. Oversees quality control activities and ensures adherence to operational and compliance standards. Sets priorities, manages workload distribution, forecasts demand, and drives workforce and budget planning. Ensures effective delivery of TMF and document management services. Supports business development initiatives. Maintains paper and electronic clinical document standards. Develops and maintains training materials, process documentation, and best practice guidelines. Represents the organization at professional meetings, client engagements, conferences, and industry seminars.
Seniority
Senior, hands-on IC with management responsibilities
