Specialist, Document & Clinical Systems (TMF)

About the Role Provides 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 a subject matter expert for electronic TMF (eTMF) end‑users and facilitates responses to audits and inspections. Collaborates closely with the CO Study Team Members and Functional Groups as the TMF System Owner. Responsibilities Collaborate with the CO Study Team, vendors, and functional group representatives to set up, review, maintain, and archive study‑specific TMFs per applicable regulations and industry standards. Document the set‑up, review, maintenance, and archival of study‑specific TMFs in TMF Plans and study‑specific TMF Indexes, including transition or migration activities. Provide guidance on eTMF usage, offering technical expertise and advice to end‑users and stakeholders. Actively support eTMF end‑users by delivering a high level of service. Review key performance indicators related to clinical trial accuracy, timeliness, and completeness of TMFs against milestone‑based projections. Communicate deficiencies identified in informal reviews to CO Study Team Leaders and upper managers. Prepare for and participate in internal or external audits/inspections, including providing audit/inspection responses and facilitating inspector access to TMFs. Participate in quarterly TMF Veeva update meetings and Computer System Validation activities as necessary. Support CO Study Team Members in Change Incident Management and Risk Assessment when requested. Attend CO Study Team meetings and eTMF QC meetings as requested. Review and provide input on TMF Standard Operating Procedures and Work Instructions to keep them current with industry best practices. Develop and maintain close working relationships with functional areas outside Clinical Operations—such as Regulatory, Biometrics, Safety Pharmacovigilance, Drug Supply, CROs, and vendors—to facilitate TMF development. Qualifications BS/BA in life science or related field, RN, or Master’s degree in life science or related field. At least 2 years of experience working directly with clinical trial documentation in a biotech, pharmaceutical company, or CRO. Experience in TMF management, eTMF, and Veeva preferred. Strong understanding of FDA regulations, GCP, ICH guidelines, and electronic technology industry standards. Knowledge of clinical study documents and experience managing trial master files in electronic format. Proficiency with MS Office and clinical systems (CTMS & eTMF). Excellent organizational, communication, problem‑solving, and analytical skills. Detail‑oriented with the ability to meet deadlines and manage priorities independently or as part of a team. Ability to explain technical and regulatory requirements to non‑technical stakeholders. Salary and Benefits The annual base salary for this position is expected to range from $89,800 to $123,000, depending on location, responsibilities, and experience. The role also offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in the company’s equity‑based long‑term incentive program. Benefits include a retirement savings plan with company match, paid vacation, holidays, and personal days, paid caregiver/parental and medical leave, and comprehensive health, prescription drug, dental, and vision coverage. EEO Statement Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize a variety of ways to meet our requirements. #J-18808-Ljbffr Neurocrine Biosciences