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

Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00. 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. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.