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
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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.
