Job Description

The TMF Document & Clinical System Associate Specialist provides operational support and maintenance for clinical systems including an Electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS). Assists in the coordination of documentation associated with conducting clinical studies. Assist Clinical Operations (CO) Study Teams and Functional Groups with management of the TMF documents, SOPs and record archiving. The TMF Document & Clinical Systems Associate/Specialist may be responsible for serve as a resource during internal or external audits and regulatory inspections of the TMF. Perform data entry and reconciliation in various clinical systems and tracking tools. Perform secondary quality check (QC) for documents submitted to the TMF. Provides support to study team including, but not limited to, maintenance of documentation, clinical tracking and information retrieval. Assist with the organization of the controlled clinical document storage on-site. Assists with off-site archiving activities (including cataloguing process and document retrieval). Assist the Sr. Specialist with documenting the set-up, review, maintenance and archival of study specific TMFs in TMF Plans and study specific TMF Index. Plans may include TMF transition and/or migration activities. Work with study team to ensure “inspection readiness” at all times. Perform additional tasks and duties as assigned. Requirements: BS/BA degree in life science or related field or RN and with some relevant experience working directly with clinical trial documentation working at a biotech/pharmaceutical company or CRO OR High School diploma and Minimum of 4 years of clinical support experience with essential regulatory documents. Understands Neurocrine's business objectives and develops understanding of Neurocrine's services and customers. Has experience in specific functional discipline while working to acquire higher-level knowledge and skills. Comfortable with tools and processes that support work conducted by functional area. Ability to work as part of a team. Strong computer skills. Good interpersonal, organizational, communications, problem-solving, analytical thinking skills. Detail oriented. Ability to meet deadlines. Good project management skills. Working knowledge of clinical study documents and managing Trial Master Files in Clinical Systems (eTMF and CTMS - Veeva preferred). Ability to process, archive, and retrieve documents in electronic format. Working knowledge of clinical trials. Good computer skills.

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