Trial Master File Specialist

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

• Work to TMF Management Plans and TMF Content Lists

• 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

• 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

GLP

• Responsible for filing, tracking, retrieving, storing, and organizing archival GLP documentation and records (paper and electronic)

• Ensure that archived GLP documentation and records (paper and electronic) are accurately catalogued and filed for expedient retrieval

• Serve as GLP archive staff member and backup to primary GLP Archivist

• May support health authority (e.g. FDA, EMA, etc.) inspection readiness, preparation, and conduct 

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. 

Education

EDUCATION AND EXPERIENCE

• Bachelors Degree or 1 year of experience

• Familiarity with GLP and GCP regulations and best practices

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  Experience working in a GCP and GLP environment preferred

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