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 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
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 team-based, cross-functional culture.
EDUCATION AND EXPERIENCE
Bachelors Degree or 1 year of experience Familiarity with GLP and GCP regulations and best practices
Experience working in a GCP and GLP environment preferred
Launch your career - Create your profile now!Create your Profile
Loading some great jobs for you...