Clinical Operations Systems Specialist

SUMMARY:

Under general guidance from the Director of Clinical Operations and the Clinical Trial Manager, you will provide technical and operational support and maintenance for clinical systems including an Electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS).  You will collaborate with clinical research colleagues and other department colleagues within Neurocrine to ensure studies are tracked correctly and study documents are accurate and complete within our clinical systems.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Collaborating on projects with Information Technology (IT) to ensure effective integration of clinical systems.

Providing technical and operational support and maintenance for clinical systems (eTMF and CTMS).

Overseeing the CTMS aspects of operational activities to support planning, initiation, conduct and close out phases of clinical studies.

Developing SOPs, process documents, training materials to support clinical systems.

Supporting Clinical Operations Directors and study teams with study set up, maintenance, and reporting in clinical systems.

Collaborating with Clinical Trial Managers and Clinical Research Associates to establish documentation process for studies and to resolve quality issues with documents.

Coordinating site regulatory document collection for assigned studies and ensure documents are filed appropriately in eTMF and are inspection ready at all times.

Participating in study team meetings by providing clinical document updates.

Performing additional tasks and duties as assigned.

QUALIFICATIONS:

Must have excellent organizational skills and be detail-oriented.  Able to work independently and to function as a team player.  Able to manage/prioritize own work.  Must have excellent interpersonal skills and excellent communication skills (verbal and written).  Knowledge of FDA regulations, Good Clinical Practices, and ICH Guidelines necessary. Computer proficiency required.

EDUCATION and/or EXPERIENCE:

AA; BA or BS degree preferred and three years experience working with clinical study documents in Clinical Systems (eTMF and CTMS).  Relevant experience in processing, archiving, and retrieving documents.  Working knowledge of clinical trials.  Knowledge of the principles and practices of traditional records management as applied to the pharmaceutical/biotech or contract research organization industry.

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