Associate, Global Patient Safety Operations (TMF) Job at Bayside Solutions, Fremont, CA

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  • Bayside Solutions
  • Fremont, CA

Job Description

Associate, Global Patient Safety Operations (TMF)

W2 Contract-to-Hire

Salary Range: $83,200 - $104,000 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

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. You will oversee GPS vendors to ensure proper collection and filing of all safety documentation into the applicable eTMF platform.

Duties and Responsibilities:

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

Requirements and Qualifications:

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

Preferred Qualifications:

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

Desired Skills and Experience

Global Patient Safety, Trial Master File, eTMF, regulatory, ICH-GCP, SharePoint, Veeva, Trial Interactive, WingSpan, FLEX, Microsoft Office, Smartsheet, Oncology, travel

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at

Job Tags

Contract work, Flexible hours,

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