Principal Specialist, Clinical Data Mgmt

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 includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in 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:

Leads, performs, and oversees data management activities for assigned clinical studies for both in-house and outsourced clinical trial data; evaluates, develops, and implements data management processes, procedures, and tools to ensure business requirements are met; collaborates within Biometrics and with Medical, DSPV, Regulatory, QC, and other internal customers to ensure high quality data in support of regulatory submissions, safety reporting, and publications. _

Your Contributions (include, but are not limited to):

Leads, performs, and oversees data management activities for clinical studies and/or clinical programs

Experience leading and supporting First-In-Human (FIH) clinical studies, including early protocol review, eCRF and database design, and alignment with dose-escalation and safety objectives

Hands-on management of data management activities for FIH studies, with emphasis on rapid data cleaning, near real-time safety data review, and support for frequent interim analyses

Close collaboration with Clinical Operations, Safety, and Biostatistics teams to support timely decision-making and governance in FIH studies

Performs hands-on clinical data management tasks to support clinical studies, including, but not limited to: reviewing study protocols, designing eCRFs, performing and coordinating user acceptance testing (UAT), documenting edit check specifications, QC’ing external data transfers, performing data quality checks/discrepancy review, and ensuring database lock activities are completed

Participate in, review, and lead development of policies, Standard Operating Procedures (SOPs), processes, and associated documents for data management; provide input on SOPs and processes in which data management is involved

Promote/advocate data management at inter- and intradepartmental meetings

Provide technical expertise to staff within Data Management, Biometrics, and other NBI departments; develop and execute training, including project-specific training, as necessary

Assist with responding to questions and findings from QA audits; ensure responses to Corrective Action Forms (CAFs) are closed out appropriately

Actively research current industry trends and share information with appropriate individuals at NBI

Recommend improvements to existing data management practices and procedures, including identifying, recommending, and implementing solutions for technology issues

Assist in the development of standardized documents within data management (both within and across projects/programs), including electronic case report forms and edit checks

Oversee screening, selection, validation, and implementation of data management software purchases and upgrades

Participate in selecting outsourcing vendors and review data management sections of proposals, including scope of work; monitor budgets as appropriate

Coordinate data management timelines for individual projects and well as clinical programs, including database lock, DSMB meetings, data review meetings, and monitoring CRO performance of data management tasks to ensure that timelines are met and that any resource issues are identified and resolved

Monitor in-house resources of assigned projects and identify potential deficiencies; work with supervisor to develop and implement a plan to overcome any obstacles

Ensure that appropriate quality control checks and audit procedures are implemented according to department SOPs

Run data review listings, issue queries, code Medical History and AE data using MedDRA dictionary and code Concomitant Medications using WHO Drug dictionary

Collaborate with database programmer to ensure NBI database standards, including CDISC/SDTM, are followed for both in-house and, if appropriate, outsourced projects

Identify areas of risk and proactively communicate issues and solutions to supervisor and/or appropriate colleagues and team members

Actively participate in data management-related NDA submission activities, as appropriate

Provide feedback, as requested, for performance evaluations. Identify strengths and areas for improvement for DM team members and work with supervisor to create a plan to develop team members

Perform other duties as assigned

Requirements:

BS/BA degree in computer science or a related discipline AND 8+ years of experience in the Pharmaceutical Industry, (either in-house/sponsor or CRO). OR

Master’s degree in computer science or a related discipline AND 6+ years of similar experience noted above OR

PhD in computer science or a related discipline AND 4+ years of similar experience noted above OR

3+ years of experience serving in a supervisory or lead capacity

Qualified candidate must have a thorough understanding of the drug development process

Experience working with GCP and CDISC/CDASH/SDTM standards

Developing SOPs/Work Instructions, and following required FDA guidance documents

Must have hands-on clinical database programming skills, including SAS, SQL, and Medidata Rave Architect

Experience with Business Objects, Rave Targeted SDV and Batch Uploader preferred.

Experience with C# programming (custom functions) is a plus

Ability to communicate effectively both verbally and in writing

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

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 communication, 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

#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.

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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