Job Title
Associate Director, Clinical Operations-TMF
Location
Bethesda, MD 20817 US (Primary)
Category
Clinical Operations
Job Type
Full-Time
Salary Range
$130,000-$155,000/YR
Education
Master's Degree
Travel
None
Job Description
- Owns Trial Master File (TMF) strategy, quality, inspection readiness, systems/processes, staff leadership, and client/study oversight.
- Provide strategic and operational leadership for the organization's TMF function, ensuring consistent inspection-ready trial documentation across several large-scale clinical programs and diverse therapeutic areas.
- Establish, maintain, and continuously improve TMF governance, processes, procedures, work instructions, and quality standards in alignment with applicable regulations, ICH GCP, sponsor requirements, and TRI policies.
- Oversee the completeness, accuracy, quality, timeliness, and overall health of the TMF across all clinical trials within TRI's portfolio.
- Serve as the senior TMF point of contact for executive leadership and key sponsor stakeholders.
- Provide department leadership as direct supervisor to Clinical Operations Managers, TMF Specialists, and other clinical operations personnel supporting TMF or related activities.
- Develop and implement TMF plans, indices, and strategies for new studies, including TMF structure, document requirements, filing conventions, and milestones.
- Oversight of Clinical Operations Trial Master File (TMF) activities, including TMF project management, documentation, and review/ collection, with depth of knowledge of regulatory (FDA requirements, GCPs/ICH guidelines), and technical processes and requirements within one or more TMF systems/tools.
- Supports one or more government or commercial contracts in multiple therapeutic areas, e.g., infectious disease (vaccines and therapeutics), oncology, medical device or drug abuse.
- Responsible for TMF project management oversight within one or more complex drug development programs while managing deliverables within budget and to well-defined timelines.
- Effectively communicates in a matrix management organization with the ability to represent the clinical team during cross-functional collaboration.
- Leads strategic initiatives to scale TMF operations across a growing clinical trial portfolio. Collaborates with Division Head and cross-functional Clinical Operations leadership on clinical strategy and vision to support clinical trial activities.
- Informs division leadership on the overall status of clinical programs/projects TMFs and of potential issues/mitigation
- Ensure documentation of processes and workflows are being followed and occurring within projected timelines and determine course of action to prevent and remediate delays. Identify gaps and propose solutions to improve efficiency and quality of deliverables. Maintain a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities.
- Support and comply with the company's Quality Management System policies and procedures. Drives innovative project and company performance improvement solutions, including corrective and preventive (CAPA) actions, as needed. Perform risk-based quality content reviews and monitor internal/external KPIs, as required by the client.
- Contributes to Corporate Initiatives, e.g., streamline and process improvement, SOP development, business development proposals, and revenue and resource forecasting.
- Includes line management responsibility and staff hiring activities. Responsible for resource management, tracking, and level of effort projections for one or more groups in the clinical operations department and/or project functional areas.
- Participate in proposal writing for government and commercial clients, budget development, and bid defense meetings, as needed.
- Supports inspection readiness of the organization and assists in department audit preparation, post inspection activities implementation and follow up.
Job Requirements
- 10 years minimum experience in the pharmaceutical or biotechnology industry including Contract Research Organization (CRO) or other global clinical trials or research environment with progressive leadership responsibility.
- At least 6 years of experience owning TMF strategy and managing or directing TMF operations and teams.
- Bachelor's Degree in life science or another health-related field (Advanced degree: PhD, PharmD, MD, or Master's Degree a plus).
- This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.
