Associate Director, Clinical Data Management

Neurocrine Biosciences; United States; Remoto; USD 172.000 - 235.000; Tempo pieno

Vantaggi offerti da questo lavoro

Retirement plan (match)

Paid vacation

Paid holidays

Leave options

Health insurance

Dental insurance

Vision insurance

Descrizione del lavoro

Neurocrine Biosciences is seeking a Clinical Data Management (CDM) leader to govern the data lifecycle across multiple studies and programs, including data collection strategy, EDC/database build, data review, reconciliation, and lock readiness. You will coordinate with cross-functional teams to ensure inspection-ready data.

The role emphasizes vendor management, process improvement, and technology enablement, including scalable EDC approaches and AI-enabled data review workflows.

Competenze

• BS/BA in Computer Science, Life Science or related field with 10+ years in Clinical Data Management
• MS/PhD with 8+ years in CDM in biotech/pharma/CRO environments
• Strong knowledge of CDM lifecycle, data standards, and SDTM/CDASH

Mansioni

• Lead CDM activities across studies/programs to ensure high-quality, inspection-ready data deliverables
• Oversee data collection strategy, EDC/database build, data review, reconciliation, and lock readiness
• Coordinate with Biostatistics, Programming, and QA to align CDM with regulatory expectations and timelines
• Manage CROs/vendors, monitor performance, quality, and timelines
• Drive process improvements, technology enablement, and modernization of CDM workflows

Conoscenze

CDM leadership

Regulatory knowledge

GCP/ICH knowledge

Data standards (CDASH/SDTM)

Cross-functional collaboration

Formazione

BS/BA in Computer Science or Life Sciences

MS in relevant field

PhD in relevant field

Strumenti

Medidata Rave

Descrizione del lavoro

Who We Are:

Neurocrine Biosciencesis 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)

At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what's ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.

About the Role:

Provides operational leadership for clinical data management activities across assigned clinical studies and programs to deliver high-quality, inspection-ready clinical data in support of clinical development, regulatory submissions, and business decision-making. Accountable for execution quality across the clinical data lifecycle within assigned scope, including data collection strategy, EDC/database build, external data integration, data review, reconciliation, database lock readiness, and vendor oversight.

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

• Leads clinical data management activities across assigned studies and/or programs to ensure accurate, complete, timely, high-quality, and inspection-ready clinical trial data deliverables
• Provides operational leadership across the clinical data lifecycle, including data collection strategy, EDC/database build, external data integration, data review, reconciliation, database lock readiness, and clinical data delivery within assigned scope
• Leads development and execution of key CDM deliverables, including data management plans, data review plans, database specifications, edit check specifications, query management processes, quality review activities, database audits, and database lock plans
• Leads or contribute to technology enablement and modernization efforts within assigned scope, including scalable EDC build approaches, standard libraries, reusable CRFs/edit checks, automation, AI-enabled data review workflows, and solutions that support end-to-end biometrics standardization
• Partners with Biostatistics and Statistical Programming to support end-to-end traceability from protocol and CRF design through SDTM-ready and analysis-ready data, reducing downstream rework and improving analysis timelines
• Monitors CDM metrics, dashboards, and operational reports to track data quality, query trends, vendor performance, cycle times, reconciliation status, lock readiness, and milestone achievement for assigned studies/programs
• Leads identification, escalation, and resolution of complex CDM issues within assigned scope, including data quality trends, database discrepancies, external data reconciliation challenges, vendor performance concerns, and cross-functional process risks
• Directs CROs, vendors, contractors, and other external partners supporting assigned CDM activities; monitor performance, deliverables, quality, timelines, issue resolution, and compliance with contractual and regulatory expectations
• Represents CDM in study team, program team, vendor, and operational meetings; communicate risks, recommendations, decisions, and progress to CDM leadership and cross-functional stakeholders
• Partners with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety/PV, Regulatory, Quality, Clinical Systems/IT, and external vendors to align CDM activities with study timelines, regulatory expectations, program goals, and business needs
• Recommends development and improvement of CDM processes, standards, templates, work practices, and governance mechanisms to increase operational efficiency, inspection readiness, quality, and consistency across studies and programs
• Ensures CDM activities are conducted in accordance with applicable regulations, Good Clinical Practice, ICH guidelines, Good Clinical Data Management Practices, SOPs, work instructions, data integrity expectations, and study-specific requirements
• Supports CDM-related inspections, audits, quality reviews, data integrity initiatives, and corrective/preventive action activities, as applicable
• Provides coaching, performance feedback, and development support to CDM employees, contractors, and matrixed team members
• Contributes to resource planning, vendor proposal review, staffing needs assessment, timeline planning, and capability development for assigned studies and programs
• Provides input into protocol design, CRF design, data standards, endpoint implementation, and cross-study consistency to enable fit-for-purpose data collection and high-quality analysis-ready data.
• Monitors industry trends, technologies, data standards, and evolving regulatory expectations related to CDM; recommend process or system improvements as appropriate
• Performs other duties as assigned

Requirements:

• BS/BA Degree in Computer Science, Life and Science related field AND 10+ years of experience in Clinical Data Management in a biopharmaceutical setting OR

• Master’s Degree in Computer Science, Life and Science related field AND 8+ years of similar experience noted above OR

• PhD AND 6+ years of similar experience noted above

• Strong experience leading Clinical Data Management activities across multiple clinical studies and/or programs in the biotechnology, pharmaceutical, or CRO environment

• Strong knowledge of the clinical data lifecycle, including data collection strategy, CRF design, EDC/database build, external data integration, data review, reconciliation, database lock, and clinical data delivery

• Working knowledge of EDC platforms and related CDM systems; Medidata Rave experience preferred

• Experience with clinical data standards, including CDASH, SDTM, controlled terminology, standard CRF libraries, and cross-study standardization

• Demonstrated ability to partner with Biostatistics and Statistical Programming to support fit-for-purpose data collection, end-to-end traceability, and analysis-ready data

• Experience overseeing CROs, vendors, contractors, and external data providers in outsourced or hybrid operating models

• Knowledge of GCP, ICH guidelines, regulatory expectations, data integrity principles, SOPs, and inspection-readiness requirements

• Experience using CDM metrics and dashboards to monitor quality, predictability, vendor performance, and database lock readiness

• Experience contributing to process improvement, technology enablement, and modernization efforts, including scalable EDC build approaches, standard libraries, automation, AI-enabled data review workflows, and/or data visualization tools

• People leadership experience, including coaching, developing, and managing CDM employees, contractors, or matrixed team members.

• Strong communication, collaboration, problem-solving, decision-making, and stakeholder management skills in a fast-paced, matrixed environment

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 $171,800.00-$235,000.00. 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 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.