Document and Clinical Systems Manager (TMF)

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). Serves as subject matter expert for Clinical information systems, including a Clinical Trial Management System (CTMS), 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 (include, but are not limited to):

• Support in development of strategic direction of clinical system(s) functionality to align with business demands and industry best practices
• Participate in development and presentation of business cases to support approval for clinical system(s) implementation
• Provides compliance guidance for the setup, maintenance and reporting from one or more clinical system(s)
• Plan/assist the set-up, review, maintenance and archival of study specific TMFs according to applicable regulations and industry standards in collaboration with the CO Study Team, Vendors, Functional Group Representatives and other Stakeholders
• Creates the documentation of 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
• Manages the Clinical System, including managing user access, user training, and system releases
• Act as lead Clinical System Admin (add organization, user help, troubleshoot errors, etc.)
• Generate and send out monthly dashboards and reports
• Evaluates key performance indicators related to clinical trial accuracy, timeliness and completeness of TMFs against milestone-based projections
• Proactively 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
• Creates 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
• Perform other duties as necessary and assigned by management

Requirements:

• BS/BA degree in life science or related field or RN AND 6+ 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. OR
• Master's degree life science or related field AND 4+ years of experience as noted above
• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
• Works to improve tools and processes within functional area
• Developing reputation inside the company as it relates to area of expertise
• Ability to work as part of and lead multiple teams
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
• Excellent computer skills
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture, impact on multiple departments/divisions
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management skills
• 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