Principal Specialist, Clinical Data Management

Neurocrine Biosciences

. Lead, perform, and oversee data management activities for assigned clinical studies and programs .

Posted 9/17/2026full-timeRemote • Massachusetts • United StatesLead💰 $130,800 - $179,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in data management for clinical studies, including protocol review, eCRF design, and adherence to CDISC/SDTM standards. Proven ability to lead teams, develop SOPs, and implement quality control measures while ensuring compliance with regulatory requirements.

Highest-signal resume keywords

Data Management LeadershipClinical Database Programming (SAS, SQL, Medidata Rave Architect)GCP and CDISC/SDTM Standards ComplianceProject Management SkillsSOP Development and FDA Guidance Adherence

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Database ProgrammingSASSQLMedidata Rave ArchitectCDISC StandardsSDTMSOP DevelopmentData Quality ChecksData Management Software ImplementationData Review Listings

Soft Skills

Effective CommunicationProblem-SolvingAnalytical ThinkingLeadership AbilityTeam Collaboration

Tools & Technologies

Business ObjectsRave Targeted SDVBatch UploaderMedDRAWHO Drug Dictionaries

Industry Keywords

Pharmaceutical IndustryFirst-In-Human StudiesQuality ControlRegulatory ComplianceData Management Practices

Tech Stack

Tools & technologies

Google Cloud PlatformSQL

About the role

Key responsibilities & impact

Lead, perform, and oversee data management activities for assigned clinical studies and programs
Lead and support First-In-Human clinical studies, including protocol review, eCRF and database design, and alignment with dose-escalation and safety objectives
Manage FIH data activities with rapid data cleaning, near-real-time safety data review, and frequent interim analyses
Collaborate with Clinical Operations, Safety, Biostatistics, Medical, DSPV, Regulatory, QC, and other internal teams
Review protocols, design eCRFs, coordinate user acceptance testing, document edit-check specifications, QC external data transfers, perform data quality checks and discrepancy reviews, and complete database locks
Develop and review policies, SOPs, processes, and associated data management documents
Provide technical expertise and training to Data Management, Biometrics, and other departments
Respond to QA audit questions and findings and ensure Corrective Action Forms are appropriately closed
Research industry trends and recommend improvements to data management practices, procedures, and technology
Develop standardized data management documents, eCRFs, and edit checks
Oversee selection, validation, and implementation of data management software purchases and upgrades
Select outsourcing vendors, review proposal data management sections and scopes of work, and monitor budgets
Coordinate project and program timelines, including database locks, DSMB meetings, data review meetings, and CRO performance
Monitor project resources, identify deficiencies, and resolve obstacles with the supervisor
Implement quality control checks and audit procedures according to department SOPs
Run data review listings, issue queries, and code Medical History, adverse event, and concomitant medication data using MedDRA and WHO Drug dictionaries
Ensure NBI database standards, including CDISC/SDTM, are followed
Identify risks and communicate issues and solutions
Participate in data management-related NDA submission activities
Provide performance feedback and support development plans for Data Management team members

Requirements

What you’ll need

BS/BA degree in computer science or a related discipline and 8+ years of experience in the pharmaceutical industry; or Master’s degree and 6+ years of similar experience; or PhD and 4+ years of similar experience
3+ years of experience serving in a supervisory or lead capacity
Thorough understanding of the drug development process
Experience working with GCP and CDISC/CDASH/SDTM standards
Experience developing SOPs/Work Instructions and following required FDA guidance documents
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 for custom functions is a plus
Ability to communicate effectively verbally and in writing
Knowledge of best practices in the functional discipline and familiarity with related business disciplines
Ability to improve tools and processes within the functional area
Ability to work as part of and lead multiple teams
Leadership ability, typically leading lower-level and/or indirect teams
Excellent computer skills
Excellent communication, problem-solving, and analytical-thinking skills
Ability to understand broader impact across departments and divisions
Ability to meet multiple deadlines across projects and programs with accuracy and efficiency
Excellent project management skills

Benefits

Comp & perks

Annual bonus with a target of 30% of earned base salary
Eligibility to participate in equity-based long-term incentive program
Retirement savings plan with company match
Paid vacation
Paid holidays
Paid personal days
Paid caregiver/parental leave
Paid medical leave
Medical coverage
Prescription drug coverage
Dental coverage
Vision coverage