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Trial Master File Specialist (TEMPORARY)

Location San Rafael, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

Duties


TMF Management

  • Facilitate the creation of the enterprise and study specific TMF management tools
  • Maintain TMF Management Plans and TMF Content Lists; work with the Study Teams to check and verify the plans and communicate the importance of each document to the Study Team based on risk level
  • Coordinate creation of the TMF filing locations within BioMarin based on the study specific TMF Content List
  • Participate in the Quality Control of documents (paper and electronic) submitted to the TMF or eTMF
  • Facilitate the review and submission of TMF records to Records Management personnel

TMF-Related Collaboration & Support

  • Support the coordination of the transfer of study-specific trial master files from the CRO
  • Participate in Study Team meetings and provide/present regular TMF metrics updates
  • Maintain awareness of study events and the associated documentation requirements through collaboration with Study Team
  • Support Study Teams and designated Study Team Content owners in understanding their TMF-related responsibilities, requirements and expectations; act as an ad-hoc member of the Study Team
  • Act as point person for Study Team TMF questions and manage close-out of TMF related issues in adherence to BioMarin processes
  • Support the Study Team in TMF document retrieval during Audits and Inspections (paper and electronic)
  • Manage the TMF content list and TMF Comprehensive Review tracker
  • Provide TMF metrics: completeness and quality of TMF documentation and content, including the percent completeness and the risk level of outstanding items on a periodic basis or as requested by DevSci management

Comprehensive Review

  • Participate in the conduct of quality review of the TMF for each assigned study on an annual basis per the time points captured in the study-specific TMF Plan.
  • Identify any corrective actions which must be addressed and assigned
  • Support the submission of documented evidence of the TMF Quality Review to the TMF
  • Support the management of TMF documentation issues throughout the lifecycle of an assigned study

Records Management

  • Participate in the implementation of standards and processes for DevSci records management to verify compliance with relevant regulations
  • Support and carry out the processes associated with the storing, archiving, indexing, scanning and classifying records:
  • Process records (e.g., track, scan, archive) in compliance with DevSci Records SOPs
  • Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to the management of records in DevSci Records
  • Provide guidance on best practices for record handling, retrieval and archival procedures
  • Provide archived DevSci records to users (e.g. internal staff and/or Auditors) for review. Oversee the provision of the required documents at the time of Regulatory Authority Inspection or internal Audits
  • Respond to TMF and non-TMF internal and/or external information inquiries related to DevSci records

Systems Development

  • Participate in the development, implementation, and maintenance of classification and filing systems per administrative, research, regulatory, legal and financial requirements
  • Manage the off-site storage of DevSci records and the contract with the storage vendor, including vendor oversight
  • Participate in the development, implementation, and maintenance of internal databases used to manage records

Skills



COMPETENCIES: OVERVIEW

Individuals in this role are expected to demonstrate good foundational Communication, Problem Solving, Planning, Prioritization and Organization, Proactivity, and Teamwork skills in order to quickly integrate into the BioMarin team-based, cross-functional culture. This includes:

  • sharing ideas and work product with competence in a clear, concise, and timely way
  • effectively facilitating small functional meetings
  • adeptly identifying critical path tasks and consistently delivering on time and as expected
  • developing and maintaining strong working relationships
  • modeling a fair, transparent and collaborative approach to work execution

The Specialist will also focus on developing skills in the Leadership and Influencing and Persuasion competency areas.

The Specialist is expected to demonstrate foundational technical skills in Regulations and Good Practices, as well as Quality Management. Skills should include:

  • an understanding of key regulatory agencies and regulatory inspection processes
  • an understanding of the objectives/purpose and key milestones/filings of each drug development phase (Pre-Clinical, phases I-IV)
  • an understanding of GxP principles, their importance, and how they apply to operational activities currently being performed

Education


EDUCATION AND EXPERIENCE

  • BA/BS in life sciences or technical area; experience in lieu of education may be considered
  • 2+ years of relevant pharmaceutical industry experience
  • Relevant certification, such as Registered Quality Assurance Professional, Certified Quality Auditor, CCRA or CCRC, Certified Clinical Research Professional, or Regulatory Affairs Certification a plus


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

About our location

San Rafael

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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