Title: 19-07986 / TMF Specialist
Location: San Rafael, CA
Industry: Biotechnology / Pharma
Position Type: Initial 12-month contract

Local residents who submit a cover letter will be viewed first

A chance to work for an amazing company, who likes to try before they buy! This mid-size company is leading the pack in their unique therapeutic area (that tugs at the heart strings)!

TOP SKILLS NEEDED:
1. TMF experience
2. Attention to detail
3. Communication
4. ability to do very monotonous work!
 
Summary- this is a JR level position (must have 1-2 years within the Pharma/Drug development industry). MUST have direct experience with working with Trail Master Files (TMF) and this must be noticeable in your resume! Other key words in your resumé are: eTMS, Veeva Vault, QMS Systems, Pharma, Drug Development. 

This role is heavy in document processing and this is not considered a 'clinical' role. 

 
Job Duties:

• 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 the 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
• 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
• 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
  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

Qualification/Education:

• BA/BS in life sciences or technical area; experience in lieu of education may be considered
• 2+ years of relevant pharmaceutical industry experience
• Demonstrate foundational technical skills in Regulations and Good Practices, as well as Quality Management

Preferred Skills/Experience:

• Relevant certification, such as Registered Quality Assurance Professional, Certified Quality Auditor, CCRA or CCRC, Certified Clinical Research Professional, or Regulatory Affairs Certification
• Understanding of key regulatory agencies and regulatory inspection processes
• Understanding of the objectives/purpose and key milestones/filings of each drug development phase (Pre-Clinical, phases I-IV)
• Understanding of GxP principles, their importance, and how they apply to operational activities currently being performed

 
*Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role*