1-617-500-6690 [email protected]
  • Full Time (Salaried)
  • Remote,

Company:  Confidential

Job Title: Program Manager – TMF

Job Number: 31443

Location: Remote, 

Job Description

Responsibilities

TMF System Owner

  • Responsible for eTMF system administration and vendor management
  • Build and present TMF training materials for study teams users
  • Responsible for TMF user management process
  • Oversee the process, templates, system, KPI and tool landscape that supports the management of TMFs
  • Support the definition and refinement of the document management strategy for the company TMFs 
  • Promote best documentation practice to line functions and provide guidance on document standards for the business functions to support inspection readiness and adherence to Good Documentation Practice

TMF Study Manager

  • Oversight of TMF staff assigned to projects, organizing meetings, action items and decision making throughout the project(s)
  • Responsible for a team of TMF Support Analyst conducting TMF filing and QC reviews
  • Can step into file documents as needed
  • Develop and assist with the implementation of the Trial Master File (TMF) Specifications 
  • Write the TMF Management Plan (TMP) and TMF Index
  • Act as the main point of contact with clinical project manager 
  • Provide routine updates on status of the TMF health and completeness
  • Responsible for TMF Quality & completeness review
  • Collect and analyze TMF metrics data to identify compliance concerns
  • Review document quality data and audit outputs to identify trends across the programs to ensure quality documentation.
  • Actively identify continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis
  • Review metrics to monitor performance against targets to ensure program deliverables are being met and productivity is aligned with company expectations
  • Ensure complete TMF is in place at time of study close/submission
  • Communicate gaps to study team, identify corrective actions, track completion and escalate effectively as needed to ensure that identified issues are addressed by study team
  • Identify and communicates trends/risks based on review at project level, and aligns across projects for consistency
  • Ensure deliverables comply with Good Clinical Practices and internal SOPs
  • Drive TMF inspection readiness activities for TMF as needed for the assigned trials
  • Responsible for definition of applicability and number of expected documents in the eTMF systems, and TMF management plan (if applicable)
  • Assigned to several Trials

Required Skills

  • Thorough knowledge of clinical Trial Master File process/activities, regulatory requirements and Good Clinical Practice
  • Has worked extensively in Medidata’s TMF system
  • Has participated in sponsor audits
  • Advanced knowledge of clinical documentation and reporting
  • Knowledge of applicable research and regulatory environments, i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP)
  • Knowledge of the national and international data protection legislation
  • Advanced ability to work both independently and in matrix team setting
  • Experience with project work or project management in a global, cross-functional multicultural and international matrix organization
  • Ability to handle multiple tasks and projects within defined timelines and balance competing priorities
  • Excellent communication, organization and tracking skills
  • Minimum 1 year supervisory/managerial experience  
  • Minimum 5 years’ experience in clinical development/clinical operations and minimum 3 years’ experience with document management systems

 

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