TMF Specialist in San Rafael, CA at Apex Life Sciences

Date Posted: 9/27/2018

Job Snapshot

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Job Description

The TMF Specialist is responsible for actively supporting the organization in the areas of: Quality Operations, Controlled Document Management, or Trial Master File (TMF) Quality and Records Management. The TMF Specialist may support the management and tracking of SOP deviations, corrective and preventative action (CAPA) plans, and data integrity plans. The TMF Specialist may be involved in supporting document control systems and processes, or coordinating inspection and audit responses and associated record-keeping. 

The TMF Specialist has foundational skills in Planning, Teamwork, Proactivity, Communication, and Problem Solving. The TMF Specialist should exhibit foundational skills in Regulations and Good Practices and Quality Management while developing technical skills in Process Analysis and Change Management. 
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 
•    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 i
•    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 
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 to verify compliance with relevant regulations
•    Support and carry out the processes associated with the storing, archiving, indexing, scanning and classifying records:
o    Process records (e.g., track, scan, archive) 
o    Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to the management of records in 
o    Provide guidance on best practices for record handling, retrieval and archival procedures
o    Provide archived 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 
Systems Development
•    Participate in the development, implementation, and maintenance of classification and filing systems per administrative, research, regulatory, legal and financial requirements 
o    Manage the off-site storage of 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

Document and Record Archive Management
•    Monitor and moderate access to Development Sciences records per the Records Management SOP; support in verifying that the processes for the management and archiving of Development Sciences records are compliant with relevant regulations
•    Effectively and efficiently archive GLP and GCP records and related information from the Development Sciences organization
•    Verify cross-functional alignment regarding records retention schedules and records disposition and destruction

•    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


EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.