Specialist – Document & Clinical Systems

Specialist – Document & Clinical Systems

Requirements

• BS/BA degree in life science or related field or RN and 2+ years working directly with clinical trial documentation working at a biotech/pharmaceutical company or CRO
• Master’s degree life science or related field and some related experience as noted above
• 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
• Demonstrates technical and strategic knowledge of applicable regulatory requirements, including electronic technology industry standards, applicable specifications, standard operating procedures, ICH/GCP guidelines and other regulatory requirements. Constantly maintains knowledge in an on-going manner
• Able to work independently and to function as a team player
• Able to manage/prioritize own work
• Knowledge of FDA regulations, Good Clinical Practices (GCPs), and ICH Guidelines necessary
• 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 is required
• Computer proficiency with MS Office

Responsibilities

• In collaboration with the CO Study Team, Vendors, Functional Group Representatives and other Stakeholders to assist in the set-up, review, maintenance and archival of study specific TMFs according to applicable regulations and industry standards
• Assist 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
• Provides guidance for the eTMF, providing technical expertise and advice to end-users and all stakeholders
• Takes a proactive role in providing a high level of service to eTMF end-users
• Provides informal review of key performance indicators related to clinical trial accuracy, timeliness and completeness of TMFs against milestone-based projections
• Informs CO Study Team Leaders and Upper Managers of deficiencies from informal reviews
• Prepares for and participates in internal or external audits/inspections including providing audit/inspection responses and facilitating inspector access to TMFs, as required
• Participates in quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Participates in CO Study Team meetings and eTMF QC meetings, as requested
• Reviews and provides input in TMF Standard Operating Procedures and Work Instructions to keep current with industry best practices for TMF management, quality and archival
• Develops and maintains close working relationships with other functional areas outside of Clinical Operations e.g. Regulatory, Biometrics, Safety Pharmacovigilance, Drug Supply, CROs, Vendors etc. to facilitate TMF development
• Perform other duties as assigned

Preferred Qualifications

No preferred qualifications provided.