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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,inspectionreadiness, 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 trialswithin TRI’s portfolio.

Serve as the seniorTMFpoint ofcontact forexecutive leadership and key sponsor stakeholders.

Provide department leadership as direct supervisor toClinical OperationsManagers, TMF Specialists,and other clinical operations personnel supporting TMFor relatedactivities.

Develop and implement TMF plans, indices, and strategies fornew studies, including TMF structure, document requirements, filing conventions,and milestones.

Oversight ofClinicalOperationsTrialMasterFile (TMF)activities,includingTMFproject management,documentation,andreview/ collection,withdepth ofknowledge of regulatory (FDA requirements, GCPs/ICH guidelines), and technical processes and requirementswithin one or more TMF systems/tools.

Supports one or moregovernmentor commercialcontracts in multiple therapeutic areas,e.g., infectious disease (vaccines andtherapeutics), oncology,medicaldeviceordrug abuse.

Responsible forTMFproject management oversight within one or more complex drug development programs while managing deliverables within budget andto well-defined timelines.

Effectively communicates in a matrixmanagementorganization with the ability torepresentthe clinical team during cross-functional collaboration.

Leads strategic initiatives to scale TMF operations across a growing clinical trial portfolio.Collaborateswith Division Head andcross-functionalClinical Operations leadershiponclinical strategyand visionto support clinical trial activities.

Informs division leadership on the overall status of clinical programs/projectsTMFsand of potential issues/mitigation

Ensure documentation of processes and workflows are being followed and occurring within projected timelines anddeterminecourse of action to prevent and remediate delays.Identifygaps and propose solutions to improve efficiency and quality of deliverables. Maintaina high levelof accuracy and attention to detail in a fast-paced environment with shifting priorities.

Support andcomply withthe 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 andmonitorinternal/external KPIs, as required by the client.

Contributes to Corporate Initiatives, e.g.,streamline andprocess improvement,SOP development, business development proposals, andrevenueand resource forecasting.

Includesline management responsibility andstaffhiring activities.Responsiblefor resource management, tracking,andlevel of effortprojectionsfor one or moregroups in the clinical operations department and/or project functional areas.

Participate in proposal writingfor government and commercial clients, budget development, and bid defense meetings, as needed.

Supports inspection readiness of the organization andassistsindepartmentaudit preparation,post inspection activities implementation andfollow up.

Job Requirements

10 years minimum experience in the pharmaceutical or biotechnology industry including Contract Research Organization (CRO) or otherglobalclinical trialsor researchenvironmentwith progressive leadership responsibility.

At least6years ofexperienceowning TMF strategy andmanaging or directingTMFoperationsand teams.

Bachelor’s Degree in life science or another health-related field (Advanced degree:PhD, PharmD, MD, orMaster’s Degreea plus).

• This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.