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.

Responsibilities

• 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
• 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
• Generates and sends out monthly dashboards and reports
• Evaluates 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
• Creates 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
• Supports CO Study Team Meetings and eTMF QC meetings, as requested

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.
• Develops reputation inside the company as it relates to area of expertise.
• 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.
• Able 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.

Pay

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.

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.