TMF Specialist, Global Patient Safety Expert

3 weeks ago

Fremont, California, United States Bayside Solutions Full time
Job Summary

We are seeking a highly skilled TMF Specialist to join our team at Bayside Solutions, Inc. as a Global Patient Safety Trial Master File Specialist.

Key Responsibilities
  • Lead the cross-functional management of Trial Master Files (TMFs) for clinical studies, ensuring compliance with applicable regulations and guidelines.
  • Oversee vendors to ensure proper collection and filing of safety documentation into the eTMF platform.
  • Communicate TMF filing status to cross-functional teams to ensure study goals are met.
  • Develop and manage eTMF plans, indexes, and associated documents as the subject matter expert.
  • 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.
  • 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.
Requirements and Qualifications
  • Bachelor's degree in biological sciences or a health-related field.
  • 2+ years of in-depth TMF management experience within Pharmacovigilance and 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 and verbal communication, interpersonal skills, and decision-making skills.
  • High sense of priority and commitment to excellence in the successful execution of deliverables.
  • Proficient with SharePoint and various eTMF platforms such as Veeva, Trial Interactive, WingSpan, and FLEX.
  • Proficiency in Microsoft Office Suite, including Outlook, Word, Excel, and PowerPoint; MS Project and Smartsheet is a plus.
  • Travel may be required up to 25% of the time.
  • Experience working with CROs/vendors and management of external resources is preferred.
  • Oncology experience, early and/or late stage, is a plus.

Bayside Solutions, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion.

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