Description
Syneos Health is seeking an Associate Director, TMF Operations to oversee the delivery of TMF and document management services. The successful candidate will have a strong understanding of eTMF systems, preferably Veeva Vault, and demonstrated expertise in resource planning, capacity management, and operational delivery.
Responsibilities:
- Oversees salary administration, interviewing and selection, employee development, performance management, job description preparation, employee counseling, and other people-management activities.
- Provides guidance to staff and managers on administrative policies, operational priorities, technical challenges, and departmental procedures.
- Facilitates cross-functional processes, resource planning, and communication across departments.
- Plans and negotiates resource allocation with functional leaders to meet business and project requirements.
- 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 for new and existing processes.
- Establishes and monitors operational metrics, KPIs, and cycle times to drive performance improvements.
- 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 and contributes to new business opportunities.
- Maintains paper and electronic clinical document standards to meet regulatory and organizational requirements.
- Develops and maintains training materials, process documentation, and best practice guidelines.
- Represents the organization at professional meetings, client engagements, conferences, and industry seminars.
- Performs other work-related duties as assigned.
- May require moderate travel (up to 50%).
Qualifications:
- 10+ years of experience in TMF Operations, Clinical Operations, or Clinical Document Management.
- Proven leadership experience, including at least 2 years of second-line management experience.
- Experience managing managers and leading large, geographically diverse teams.
- Strong understanding of eTMF systems, preferably Veeva Vault.
- Demonstrated expertise in resource planning, capacity management, and operational delivery.
- Experience within a CRO, pharmaceutical, or biotechnology environment preferred.
- Strong knowledge of GCP, regulatory requirements, and TMF quality standards.
- Excellent stakeholder management, communication, and problem-solving skills.