Trial Master File Specialist
770 Lindaro Street San Rafael, CA 94949
Bayside Solutions is seeking a Trial Master File Specialist to be part of our client’ s team in San Rafael. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Trial Master File Specialist
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- 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
- Act as point person for Study Team TMF questions and manage close-out of TMF related issues in adherence to client 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
- 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
- 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
- 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
- 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
Summary of Qualifications:
- Bachelor’ s degree or 1 year of experience
- Familiarity with GLP and GCP regulations and best practices
- Experience working in a GCP and GLP environment preferred
- Individuals in this role are expected to demonstrate good foundational Communication, Problem Solving, Planning, Prioritization and Organization, Proactivity, and Teamwork skills.
- CCRA, CCRC or Certified Quality Auditor Certifications/Licenses are nice to have.