Eikon Therapeutics
Manager, Trial Master File (TMF) Operations
Eikon Therapeutics, Jersey City, New Jersey, United States, 07390
Manager, Trial Master File (TMF) Operations
Millbrae, CA; Jersey City, NJ Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. The Manager, TMF Operations role ensures a complete, accurate and high-quality Trial Master File (TMF) as the subject matter expert through proper, consistent documentation and proactive partner relationship with the clinical study teams. This role will work directly with all functions who contribute to the TMF to ensure regulatory inspection readiness for clinical trials, including TMF set-up, document collection and filing, monitoring quality, timeliness, and completeness. Responsibilities: Ensures all TMF related tasks meet expectations and are delivered in accordance with applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and executed study-specific processes/requirements. Sets up the TMF and Expected Document Lists (EDLs) by collaborating with relevant members of the study team. Facilitates the creation, review, and approval of TMF plans and filing structures. Performs periodic TMF Quality, Timeliness and Completeness Reviews to maintain an inspection readiness state throughout the clinical trial. Supports documentation collection and filing activities, including document scanning and indexing, technical QC of uploaded documents, and initiation of Quality Issue workflow when document issues are identified. Qualifications: 6+ years of experience with a Bachelor's degree; or 4+ years of experience with a post graduate degree. Experience in a pharmaceutical/biotechnology/CRO organizations TMF/records management function preferred. Experience in TMF management, knowledge of the TMF Reference Model, ALCOA+ standard, Good Documentation Practices, or relevant working experience in pharmaceutical/scientific environments. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment. #J-18808-Ljbffr
Millbrae, CA; Jersey City, NJ Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. The Manager, TMF Operations role ensures a complete, accurate and high-quality Trial Master File (TMF) as the subject matter expert through proper, consistent documentation and proactive partner relationship with the clinical study teams. This role will work directly with all functions who contribute to the TMF to ensure regulatory inspection readiness for clinical trials, including TMF set-up, document collection and filing, monitoring quality, timeliness, and completeness. Responsibilities: Ensures all TMF related tasks meet expectations and are delivered in accordance with applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and executed study-specific processes/requirements. Sets up the TMF and Expected Document Lists (EDLs) by collaborating with relevant members of the study team. Facilitates the creation, review, and approval of TMF plans and filing structures. Performs periodic TMF Quality, Timeliness and Completeness Reviews to maintain an inspection readiness state throughout the clinical trial. Supports documentation collection and filing activities, including document scanning and indexing, technical QC of uploaded documents, and initiation of Quality Issue workflow when document issues are identified. Qualifications: 6+ years of experience with a Bachelor's degree; or 4+ years of experience with a post graduate degree. Experience in a pharmaceutical/biotechnology/CRO organizations TMF/records management function preferred. Experience in TMF management, knowledge of the TMF Reference Model, ALCOA+ standard, Good Documentation Practices, or relevant working experience in pharmaceutical/scientific environments. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment. #J-18808-Ljbffr