Sr. Manager, Clinical Data Management

Neurocrine Biosciences • San Diego, CA

3d • $154,500 - $211,000

About The Position

The Sr. Manager, Clinical Data Management leads staff and clinical data management activities, ensuring high-quality deliverables across one or more clinical programs. The role oversees the design, development, implementation, and validation of clinical study databases; 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. The position combines functional leadership with hands-on clinical data management work, including support for study-level data management and NDA submission activities.

Requirements

• Bachelor's degree and 8 or more years of relevant experience; or a master's degree and 6 or more years of related experience; or a PhD and 4 or more years of related experience.
• Previous managerial or functional management experience.
• Broad understanding of the 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.
• Ability to work as part of and lead multiple teams; strong leadership skills and experience managing teams.
• Excellent computer, communication, problem-solving, analytical thinking, and project management skills.
• Ability to see broader cross-departmental and divisional impacts and meet multiple project or 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 applicable FDA and industry-standard guidelines, including FDA and ICH regulations.
• Demonstrated proficiency in providing data management leadership and expertise from study protocol through data submission.
• Experience effectively overseeing or leading 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 within assigned programs, ensuring required tasks are completed.
• Hire, train, mentor, oversee, and evaluate Clinical Data Management staff and/or Clinical Database Programmers.
• Contribute to assessing departmental needs for software tools and applications.
• Assist with managing data management budgets and timelines to meet project and fiscal goals.
• Represent data management on cross-functional committees to improve process efficiency and GxP compliance.
• Provide technical clinical data management leadership and serve as a resource for the Clinical Data Management team and other departments.
• Ensure clinical data management standards are implemented, followed, and kept up to date.
• Research industry trends and recommend improvements to data management practices, procedures, and systems.
• Participate in selecting outsourcing vendors and CROs; review data management proposals, scopes of work, and RFPs; and 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 relevant team members.
• Manage in-house and CRO resources, identify potential deficiencies or timeline conflicts, and develop and implement plans to address obstacles.
• Serve as Clinical Data Management Lead on 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.
• Serve as a lead contributor to data management-related NDA submission activities, as appropriate.
• Respond to QA audit questions and findings, including CAPA matters, and ensure Corrective Action Form responses are appropriately closed.
• Perform other duties as assigned.

Benefits

• 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.
• Annual bonus with a target of 30% of earned base salary.
• Eligibility to participate in the equity-based long-term incentive program.

What This Job Offers

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