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Principal TMF Process Owner

Principal TMF Process Owner

ID 
2017-1354
Job Location 
US-NC-Chapel Hill
Type 
Regular Full-Time

More information about this job

Overview

The Principal TMF Process Owner will be the single point of accountability for processes and systems supporting the establishment and maintenance of high quality and compliant Trial Master Files (TMFs) within Rho.   This is an excellent opportunity for a highly motivated individual to work collaboratively within all areas of the company as well as manage daily the associated TMF initiatives, including but not limited to facilitating responses to audit/inspections, establishing the end-to-end design and management, maintenance of structure and ensuring appropriate oversight for all TMF systems.

Responsibilities

  • Responsible for effective business support for business users of Trial Master File (TMF) across study teams, functions and vendor partners. Provides leadership, supervision, strategic alignment and management and industry representation externally.

  • Builds collaborative cross-functional relationships to drive efficiency, sustainability, and the delivery of business objectives.

  • Forecasting of TMF management related costs, including resourcing, eTMF solution costs and other budget related items. Provides input on Rho RFPs for the costs of TMF management.

  • Establish appropriate oversight for TMF management processes, including ensuring necessary vendor oversight is in place.

  • Establish process controls, including the identification of key performance measures and indicators by which processes will be assessed. Use measures to direct efforts to improve processes.

  • Review TMF management process performance indicators and intervene accordingly.

  • Resolve conflicts on TMF management process issues that involve cost/quality or other significant trade-offs.

  • Ensure TMFs are inspection-ready in timeframe established by process and specific study.

  • Liaise with relevant functional leaders regarding responses to audits, inspections and CAPA management associated to TMFs and the management process.

  • Approve all relevant policies and procedures related to the TMF management process. Responsible for managing procedural document revisions, updating and approving as needed.

  • Review and provide comment to relevant policies and procedures that have a TMF management component.

  • Selects the appropriate technology support solutions and requirements for the changing landscape of TMF management.

  • In association with the Technology group, manage system software contracts.

  • Point of contact for FDA, regulatory agencies, and/or Sponsors during audits.

  • Travel (approximately 10%). Anticipated activities may include attendance at client meetings, conferences, study team meetings or audits.

Qualifications

  • BA/BS required, advanced degree with scientific or health-care training preferred.
  • A minimum of 10 years’ experience working in a clinical research/clinical development industry.
  • TMF experience required, including leading or responsibility for TMF management for an organization, document management/TMF technology solutions.
  • Previous process owner experience highly desirable. Oversight and delivery of large and/or multiple process improvement projects.
  • Five years of project management/trial experience with working knowledge of clinical trial design, execution and clinical operations/development highly desirable.
  • Demonstrable knowledge of drug development processes.
  • Strong knowledge of global regulatory and legal requirements pertaining to the TMF; experience with the Reference Model created through the DIA is desirable.
  • Records and information management experience highly desirable.
  • Ability to interact with and influence many levels of technical and business staff.
  • Knowledge of process management tools and techniques desirable.
  • Excellent working knowledge of FDA & ICH/GCP regulations and guidelines.
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.