Associate, Global Patient Safety Operations (TMF)

Bayside Solutions; California; Hybrid; USD 83,000 - 104,000; Full time

Job summary

An established industry player is seeking a Global Patient Safety Trial Master File Specialist to lead TMF management for clinical studies. This hybrid role involves overseeing vendor compliance, ensuring the accurate collection and filing of safety documentation, and collaborating with cross-functional teams. The ideal candidate will have a strong background in TMF management, excellent communication skills, and a commitment to quality. This is an exciting opportunity to contribute to impactful clinical research and work in a dynamic environment that values collaboration and excellence.

Qualifications

• 2+ years of TMF management experience in Pharmacovigilance/Safety.
• Strong knowledge of international safety reporting regulations.
• Excellent communication and decision-making skills.

Responsibilities

• Lead cross-functional management of TMFs for clinical studies.
• Ensure compliance with SOPs, GCP, and ICH guidelines.
• Perform quality control of TMF documents and oversee metrics.

Skills

Global Patient Safety

Trial Master File (TMF)

eTMF

regulatory compliance

ICH-GCP

SharePoint

Veeva

Microsoft Office Suite

Smartsheet

Oncology

Education

Bachelor's degree in biological sciences or health-related field

Tools

Microsoft SharePoint

Veeva

Trial Interactive

WingSpan

FLEX

Microsoft Office Suite

Microsoft Project

Smartsheet

Job description

Associate, Global Patient Safety Operations (TMF)

Associate, Global Patient Safety Operations (TMF)

This range is provided by Bayside Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$40.00/hr - $50.00/hr

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

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 www.baysidesolutions.com.

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

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 www.baysidesolutions.com.

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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Administrative and Science

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