Sr. Specialist, Document & Clinical Systems

About the role

Provides strategic support to Clinical Operations (CO) Study Teams by creating plans for the quality, compliance and inspection-readiness of all Neurocrine trial master files (TMF). The role serves as subject matter expert for electronic TMF (eTMF) end-users, and facilitates responses to audits/inspections.

Collaborates closely with the Clinical Operations Study Team Members and Functional Groups as TMF System Owner.

Your Contributions

• In collaboration with the CO Study Team, Vendors, Functional Group Representatives and other Stakeholders, plan/assist the set-up, review, maintenance and archival of study specific TMFs according to applicable regulations and industry standards
• Fullly documents 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
• Serves as subject matter expert 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
• Lead monthly eTMF meetings for internal CO Study Team
• Administering Clinical System, including managing user access, user training, and system releases
• Generate and send out monthly dashboards and reports
• Provides informal review of key performance indicators related to clinical trial accuracy, timeliness and completeness of TMFs against milestone-based projections
• Prepares for and participates in internal or external audits/inspections including providing audit/inspection responses and facilitating inspector access to TMFs, as required
• Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested
• Supports CO Study Team meetings and eTMF QC meetings, as requested
• Writes/edits TMF Standard Operating Procedures and Work Instructions to keep current with industry best practices for TMF management, quality and archival
• 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
• 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
• Performs other duties as necessary and assigned by management

Requirements

• BS/BA degree in life science or related field or RN AND 4+ years working directly with clinical trial documentation working at a biotech/pharmaceutical company or CRO. Additional years of experience in lieu of educational requirement may be considered.
• ORMaster’s degree life science or related field AND 2+ years of experience as noted above
• 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

Pay

The annual base salary we reasonably expect to pay is $110,800.00-$151,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.

Benefits

• Retirement savings plan (with company match)
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans