Director, Trial Master File (TMF) Operations Job at EPM Scientific, San Francisco, CA

dkVMS2NXakhsbXRwdW1PaDJ2eDBxS25VQVE9PQ==
  • EPM Scientific
  • San Francisco, CA

Job Description

Job Type: Full-time

Salary: $200K-$215K

Location: Hybrid - San Francisco Bay Area, CA / Jersey City, NJ / NY, NY

Company Summary: A pre-IPO clinical stage biotech developing therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised nearly a $1 billion continue advancing their clinical programs.

The Opportunity: The Director, TMF Operations will lead TMF operations for all of the clinical trials across the organization. You will need to drive change and progress at a strategic level, and will therefore, need to possess the necessary communication and collaboration skills to ensure TMFs are complete, accurate, and compliant with regulations.

Responsibilities:

  • Leading the TMF Operations function to support Clinical Research and Development
  • Managing and overseeing the TMF Operations team, including hiring, training, and performance management
  • Maintaining strong relationships with TMF third party vendors, including driving resolution of issues and remediation activities
  • Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices
  • Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements
  • Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle
  • Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival
  • Develop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, CRO, and other stakeholders

An ideal candidate for this role MUST have…

  • Minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree
  • Proven leadership experience in an insourced biotech organization
  • Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations
  • Experience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms

Benefits:

  • Pre-IPO biotech company
  • Competitive salary with comprehensive benefits (100% medical coverage)
  • 401K contribution

Job Tags

Full time,

Similar Jobs

KellyMitchell Group

Entry Level Compliance Support Job at KellyMitchell Group

 ...Job Summary: Our client is seeking an Entry Level Compliance Support to join their team! This position is located in White Plains, New York. Duties: Review and maintain documentation for disciplinary and supervision cases, ensuring accuracy and confidentiality... 

REACH Solar

Solar Appointment Setter Job at REACH Solar

 ...consultations (Zoom) Generate your own leads through proven systems (training included) Help homeowners cut utility bills with clean...  ...Anyone hungry to build income, skills, and freedom No experience required well train you from scratch. If you bring consistency... 

Ramseys Diamond Jewelers

Master Jeweler/ Diamond setter Job at Ramseys Diamond Jewelers

Company Description Ramsey's Diamond Jewelers, founded in 1958, has evolved from a custom jewelry manufacturer to a premier diamond jewelry retailer. Located at 701 Veterans Blvd in Metairie, our store boasts the largest selection of engagement rings in Louisiana. Renowned...

Surya Carpet

Jr. Ecommerce Account Manager Job at Surya Carpet

 ...annual list of America's fastest growing privately held companies ten times. Job Description: Were looking for a driven Junior Ecommerce Account Manager to join our thriving team. In this role, youll manage various aspects of our ecommerce businessfrom building... 

Ultimate Staffing

Data Entry Job at Ultimate Staffing

 ...Temporary Data Entry Clerk - Pomona Office We are currently seeking a Temporary Data Entry Clerk. This role will focus on logistics data...  ...standards. Qualifications: Proficiency in Microsoft Excel, including formulas and data manipulation. Previous experience...