Global Patient Safety (GPS) Trial Master File (TMF) Specialist - Contractor

Global Patient Safety (GPS) Trial Master File (TMF) Specialist - Contractor

The Opportunity:

As a Global Patient Safety (GPS) Trial Master File (TMF) Specialist, you will be the GPS TMF lead in the cross-functional management of TMF for clinical studies. The responsibilities will include the oversight of GPS vendors to ensure proper collection and filing of all safety documentation into the applicable eTMF platform.

Responsibilities:

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  Serve as the GPS TMF lead in the cross-functional management of TMFs for all clinical studies.
  
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  Adhere to applicable Standard Operating Procedures (SOP), Good Clinical Practice (GCP), International Conference on Harmonization (ICH) Guidelines, and ALCOA+ principles.
  
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  Communicate TMF filing status to cross-functional teams to ensure study goals are met.
  
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  Co-author, review, and manage all all eTMF Plans, Index, applicable SOPs/guidance documents and associated documents as the GPS subject matter expert (SME).
  
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  Perform quality control of uploaded documents to ensure accurate uploading and proper indexing.
  
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  Establish and manage quality oversight of study TMFs, including TMF metrics and KPIs.
  
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  Partner with CROs/vendors and cross-functional team members to manage TMF activities, as needed.
  
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  Maintain vendor and internal processes for cataloging, filing, retrieving, saving and transferring TMF records.
  
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  Develop successful working relationships with CROs/vendors on TMF management.
  
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  Support audit and inspections for GPS TMF related activities.
  
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  Actively contribute in the eTMF uploads for all relevant clinical studies, as needed.
  
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  Participate in other GPS activities as appropriate.
  

Required Skills, Experience and Education:

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  Bachelor’s degree preferably in biological sciences or health-related field.
  
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  2 years minimum of in depth TMF management experience within Pharmacovigilance/Safety.
  
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  Strong knowledge and understanding of international safety reporting regulations and safety reporting compliance.
  
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  A Strong working knowledge with the DIA TMF Reference Model or equivalent, ICH-GCP, ALCOA+ standard and regulatory requirements related to document management.
  
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  Proven ability to successfully oversee TMFs including development of relevant processes and policies.
  
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  Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace.
  
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  Excellent written/verbal communication, interpersonal skills and decision-making skills.
  
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  High sense of priority and commitment to excellence in the successful execution of deliverables.
  
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  Profient in SharePoint and various eTMF platforms such as Veeva, Trial Interactive, WingSpan, FLEX.
  
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  Proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
  
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  Travel may be required, if remote (~25%).
  

Preferred Skills:

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  Experience working with CROs/vendors and management of external resources.
  
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  Oncology experience, early and/or late stage.