Sr. Manager, Clinical Data Management

Neurocrine Biosciences • San Diego, CA

2d • $154,500 - $211,000

About The Position

The Sr. Manager, Clinical Data Management leads staff and data management activities for one or more clinical programs, ensuring high-quality deliverables and the design, development, implementation, and validation of clinical study databases. The role leads clinical studies and programs, maintains data management standards across studies, and contributes to strategic planning and execution of the Clinical Data Management function within Biometrics.

This position provides technical and people leadership, including managing staff and internal and outsourced resources, supporting study execution from protocol review through database lock and submission, and contributing to process efficiency, GxP compliance, risk mitigation, and continuous improvement. The role also supports NDA submission activities and works across clinical teams and other departments.

Requirements

• BS/BA degree and 8+ years of relevant experience, or a master's degree and 6+ years of related experience, or a PhD and 4+ years of related experience; previous managerial or functional management experience is also required.
• Broad understanding of processes, procedures, and systems used by the team, and familiarity with underlying concepts in other disciplines within the function.
• In-depth understanding of how the discipline integrates within the function and contributes to Neurocrine's business objectives.
• Knowledge of functional best practices and familiarity with broader concepts in related business disciplines.
• Ability to improve tools and processes within the functional area and an established reputation within the company in the area of expertise.
• Ability to work as part of and lead multiple teams; demonstrated leadership and team management skills.
• Excellent computer, communication, problem-solving, analytical thinking, and project management skills.
• Ability to understand broader impacts across departments and divisions and meet multiple project/program deadlines accurately and efficiently.
• Attention to detail and confidentiality.
• Proficiency with Word, Excel, and PowerPoint.
• Thorough understanding of the drug development process.
• Proficiency with Medidata Rave.
• Proficiency with MedDRA and WHO Drug coding dictionaries.
• Demonstrated expertise working on an NDA submission.
• Proficiency with SAS.
• Thorough knowledge of Good Clinical Data Management Practices, CDISC/CDASH/SDTM, and FDA and ICH regulations and other industry-standard guidelines.
• Demonstrated proficiency providing data management leadership and expertise from study protocol through data submission.
• Experience effectively overseeing or leading people, including direct reports, and organizing tasks.

Nice To Haves

• Knowledge of Medidata Rave Architect, Coder, eCOA, T-SDV, and Amendment Manager.
• Knowledge of other programming languages, including C# for custom functions.
• Working knowledge of Business Objects.

Responsibilities

• Lead and oversee data management activities and timelines for clinical studies across one or more programs, ensuring all required data management tasks are completed.
• Hire, train, mentor, oversee, and evaluate Clinical Data Management staff and/or Clinical Database Programmers.
• Contribute to assessment of departmental needs for software tools and applications.
• Assist with management of data management budgets and timelines to meet project and fiscal goals.
• Represent data management on cross-functional committees focused on process efficiency and GxP compliance.
• Provide technical leadership and act as a resource for the Clinical Data Management team and other company departments.
• Ensure clinical data management standards are implemented, followed, and kept up to date.
• Research industry trends and recommend improvements to practices, procedures, and systems.
• Participate in selection of outsourcing vendors and CROs; review data management proposals, scopes of work, and RFPs; monitor budgets and change orders.
• Oversee development and maintenance of standardized data management documents, including electronic case report forms and edit checks.
• Provide data management leadership and strategic input at Clinical Subteam and Study Team meetings, including input on data collection plans and risk-based monitoring.
• Identify risks and proactively communicate issues and mitigation solutions to management and team members.
• Manage internal and CRO resources, identify deficiencies or timeline conflicts, and develop and implement solutions.
• Serve as Clinical Data Management Lead for one or more studies and perform hands-on tasks, including protocol review, eCRF design, UAT, edit-check specification documentation, external data QC, eCRF data review, SAS dataset runs, medical history/adverse event/concomitant medication coding, and database lock activities.
• Contribute to data management-related NDA submission activities as appropriate.
• Respond to QA audit questions and findings, including CAPAs, and ensure Corrective Action Form responses are appropriately closed.
• Perform other duties as assigned.

Benefits

• Annual bonus with a target of 30% of earned base salary.
• Eligibility to participate in an equity-based long-term incentive program.
• Retirement savings plan with company match.
• Paid vacation, holiday, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage, subject to applicable plan terms and conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior