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TMF Specialist
Ref No.: 18-12901
Location: San Rafael, California
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

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