Neurocrine Biosciences · 11 hours ago
Principal Specialist, Clinical Data Mgmt
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$131K/yr - $179K/yr
6+ years expNeurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients. The Principal Specialist in Clinical Data Management will lead and oversee data management activities for clinical studies, ensuring high-quality data in support of regulatory submissions and safety reporting.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
Qualification
Required
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)
Master's degree in computer science or a related discipline AND 6+ years of similar experience noted above
PhD in computer science or a related discipline AND 4+ years of similar experience noted above
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
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
Preferred
Experience with Business Objects, Rave Targeted SDV and Batch Uploader
Experience with C# programming (custom functions) is a plus
Benefits
Annual bonus with a target of 30% of the earned base salary
Eligibility to participate in our equity based long term incentive program
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
Company
Neurocrine Biosciences
Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.
1001-5000 employees
H1B Sponsorship
Neurocrine Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (9)
2023 (8)
2022 (2)
2021 (5)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$260MKey Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO
Leadership Team
Matt Abernethy
Chief Financial Officer
D
Dimitri Grigoriadis
VP, Research
Recent News
BioWorld Financial Watch
2026-01-16
Company data provided by crunchbase