Neurocrine Biosciences
Location
San Diego, California
Salary
$89,800 - $123,000 / YEAR
Supports Clinical Operations by managing the quality, compliance, and inspection-readiness of Trial Master Files (TMF). Acts as a subject matter expert for eTMF systems, facilitating audits and collaborating with cross-functional teams to maintain study documentation.
Requires a Bachelor's degree in life sciences or related field with 2+ years of clinical trial documentation experience, or a Master's degree with related experience. Must possess strong knowledge of GCP, ICH guidelines, FDA regulations, and proficiency in eTMF/CTMS systems like Veeva.
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). May serve as subject matter expert for 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): In collaboration with the CO Study Team, Vendors, Functional Group Representatives and other Stakeholders to assist in the set-up, review, maintenance and archival of study specific TMFs according to applicable regulations and industry standards Assist with documenting the 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 Provides guidance 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. Provides informal review of key performance indicators related to clinical trial accuracy, timeliness and completeness of TMFs against milestone-based projections 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 Reviews and provides input in 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 Perform other duties as as assigned Requirements: BS/BA degree in life science or related field or RN AND 2+ years working directly with clinical trial documentation working at a biotech/pharmaceutical company or CRO OR Master’s degree life science or related field AND some related experience as noted above Understands Neurocrine's business objectives and develops understanding of Neurocrine's services and customers Has experience in specific functional discipline while working to acquire higher-level knowledge and skills Comfortable with tools and processes that support work conducted by functional area Ability to work as part of a team Strong computer skills Good interpersonal, organizational, communications, problem-solving, analytical thinking skills Detail oriented Ability to meet deadlines Good project management skills 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 Able to work independently and to function as a team player Able to manage/prioritize own work 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 #LI-RS1 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 $89,800.00-$123,000.00. 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 20% 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. We are a top place to work. Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma™ 2025. We were also named a Great Place to Work® Certified company. ©2025 Fortune Media IP Limited. All rights reserved. Used under license. OUR VALUES: PASSION: We are driven and love what we do. We are committed to our goals and to making a difference. INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up. COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed. INNOVATION: We seek and create optimal solutions. TENACITY: We do not quit. We adapt. We accomplish what others cannot. Come join our team during this exciting time of growth and opportunities!
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