770 Lindaro Street
Industry: Clinical & Scientific
Job Number: 16095
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:
- 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 company 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
- 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 company 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
Summary of Qualifications:
- 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 sharing ideas
- 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
- As expected developing and maintaining strong working relationships modeling a fair, transparent and collaborative approach to work execution an understanding of key regulatory agencies
- 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