Vacancy Name

Associate Director, TMF Operations and Clinical Operations Analytics

Vacancy No

VN520

Employment Type

Full Time

Location of role

Conshohocken,PA

Gaithersburg, MD

Department

Clinical Operations

Key Responsibilities

The Associate Director of Strategic TMF Operations and Clinical Operations Analytics is a vital member of the Clinical Operations Leadership Team within the Clinical Science and Medical Affairs organization. This role provides strategic leadership and oversight of Trial Master File (TMF) operations, enhancing functionality, efficiency, scalability, and quality. The ideal candidate will possess TMF system and process expertise, exceptional vendor oversight, and a strong foundation in inspection readiness and support.

Beyond TMF responsibilities, this position oversees Clinical Operations reporting, metrics, KPIs, and analytics. The role involves collaborating with senior leaders and key stakeholders to establish, manage, and generate reports and analytics that support performance measurement, delivery optimization, and continuous improvement. This onsite position can be located at either the Gaithersburg, MD or Conshohocken, PA offices. 

KEY RESPONSIBILITIES

TMF Operations: Accountable for the company's Trial Master File support model, processes, and systems

• Responsible for oversight and management of TMF vendors and associated processes for the TMF

• Primary point of contact related to TMF processes and systems and study specific TMF support, as appropriate.

• Develop and oversee global TMF-related standards, standard operating procedures (SOPs) and corresponding controlled documents that are in line with relevant regulations (e.g., ICH-GCP, and regulatory requirements such as EMA and MHRA) and industry best practices (e.g., CDISC Trial Master File Reference Model). 

• Provide expertise and strong leadership to ensure inspection readiness and facilitate seamless support of audits and regulatory inspections.

• Review and provide expert TMF operations input into clinical documents, particularly study plans.

• Develop, generate, analyse, and present to leadership standard TMF metrics/KPIs to demonstrate TMF health.

• Lead the continuous evolution, implementation, and oversight of TMF support model. 

• Provide operational leadership to TMF vendor budget negotiations and management of TMF operations spend. 

• Lead and manage the relationship with TMF-related vendors, ensuring appropriate contract scope, budgets, vendor performance and 

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