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Trial Master File (TMF) Specialist

Location San Rafael, California

JOB DESCRIPTION

Job Title:

TMF Specialist

Department / Cost Center:

Development Sciences Quality

Reports to (Job Title):

Sr. Director, Development Sciences Quality

Job Code:

Location:

San Rafael

Date Prepared:

January 26, 2020

Full-Time     Part-Time

Regular     Temporary

Exempt     Non-Exempt

OVERVIEW:Development Sciences Quality (DSQ)

The Development Sciences Quality (DSQ) group is focused on partnering with Development Sciences functional groups, project teams and study teams to proactively promote, facilitate and verify the implementation of, and adherence to, good quality practices across the drug development lifecycle in order to be inspection ready at all times. DSQ achieves this by implementing, maintaining and continuously improving a quality management system which includes robust quality operations oversight, controlled document management, eTMF and records management, inspection readiness and response support and training development and delivery.

SUMMARY DESCRIPTION

The Specialist is responsible for actively supporting the Development Sciences Quality organization in the areas of Trial Master File (TMF) Management and Quality.  The Specialist achieves this through oversight of the documents filed to the eTMF,quality review and quality control of documents, reviewing trends and/or metrics gathered from the eTMF and providing guidance and recommendations to the study teams on best TMF management practices including resolving issues, review organization of documents to ensure completeness andfacilitating retrieval during audits and inspections.

The Specialist has foundational skills in Planning, Teamwork, Proactivity, Communication, and Problem Solving. The specialist should exhibit foundational skills in Regulations and Good Practices and Quality Management while developing technical skills in Process Analysis and Change Management.

KEY RESPONSIBILITIES:

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

CAREER DEVELOPMENT

BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway in DSQ has been defined and is available to employees of BioMarin.

PEOPLE MANAGEMENT

No people management responsibilities.

EDUCATION AND EXPERIENCE

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

WORK ENVIRONMENT / PHYSICAL DEMANDS / TRAVEL

The employee may frequently be required to sit and talk or hear.  The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.  The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

EQUIPMENT

Computer work utilizing common business software programs.

CONTACTS

Internal:  Clinical Operations; Data Management; Pharmacovigilance; Medical Writing; Clinical Sciences; Pharmaceutical Sciences; Corporate GxP Compliance; Regulatory Affairs; TechOps Quality; Legal; Project Management; Computer System Validation Quality; IT.

External:  CROs; other clinical vendors and suppliers

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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