Who We Are:
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio include FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (_*in collaboration with AbbVie_)
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). 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.
