Sr. Manager, Clinical Data Management

Neurocrine Continental; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Neurocrine Biosciences is seeking a Clinical Data Management Lead to oversee staff and data management activities across one or more clinical programs. You will design, development, implementation, and validation of clinical study databases, maintain data management standards, and contribute to strategic planning within Biometrics.

You will lead DM staff, oversee budgets, coordinate with CROs, and ensure GxP compliance, while driving continuous improvement in data capture, validation, and

Qualifications

• Lead data management activities for clinical studies and ensure DM tasks are completed.
• Hire, train, and supervise CDM staff and CRO data programmers.
• Oversee budgeting, timelines, and vendor management for DM programs.
• Ensure GxP compliance and implement standardized DM documents and processes.

Responsibilities

• Lead data management activities and ensure DM tasks are completed for studies.
• Hire, train, mentor, and evaluate CDM staff and programmers.
• Assess software/tool needs for data management.
• Manage DM budgets and timelines to meet goals.
• Represent DM on cross-functional committees for improved processes and GxP compliance.
• Provide DM leadership and act as a technical resource within Biometrics.
• Ensure DM standards are implemented and up-to-date.
• Research industry trends and propose DM improvements.
• Participate in vendor/CRO selection; review proposals and budgets.
• Develop and maintain standardized DM documents (eCRFs, edit checks).
• Provide DM leadership at subteam and study meetings with risk planning.
• Identify risks and communicate solutions to management.
• Manage in-house and CRO resources; resolve timeline issues.
• Lead CDM on studies; hands-on tasks (protocol review, eCRFs, UAT).
• Lead NDA submissions as appropriate.
• Respond to QA audits.

Skills

Leadership

Data management

Staff management

Budget management

Vendor management

GxP compliance

SAS

eCRF design

UAT

Cross-functional collaboration

Tools

SAS

EDC systems

Job description

Who We Are:

Neurocrine Biosciences is 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 )

About the Role:

Responsible for leading and managing staff and data management activities and ensuring high-quality deliverables on one or more clinical programs; responsible for the design, development, implementation, and validation of clinical study databases within the program. Leads one or more clinical studies and programs. Maintains data management standards across studies within and across clinical programs. Contributes to the strategic planning and execution of the Clinical Data Management function within Biometrics. _

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

• Serve in a leadership role with responsibility to perform and oversee data management activities and timelines for clinical studies within one or more clinical programs to ensure all DM tasks are completed for all projects within the program(s)


• Hires, trains, mentors, oversees, and evaluates performance of Clinical Data Management Staff and/or Clinical Database Programmers to support the collection and validation of clinical study data


• Contributes to the assessment of department needs for software tools and applications


• Assist with management of DM-related budget and timelines to ensure project and fiscal goals are met


• Serve as the data management representative on cross-functional committees to improve process efficiency and GxP compliance within data management


• Contribute strong technical clinical data management leadership to the Clinical Data Management function with Biometrics and acts as a technical resource for the Clinical Data Management team as well as for those in other NBI departments (eg, nonclinical, medical affairs)


• Ensures that clinical data management standards are implemented/followed and are up-to-date


• Actively research current industry trends, recommend improvements to existing data management practices, procedures, and systems (continuous improvement)


• Participate in selecting outsourcing vendors and CROs; review data management sections of proposals, including scope of work and RFPs; monitor budgets and change orders as appropriate.


• Oversee the development and maintenance of standardized documents within data management (both within and across studies/programs), including electronic case report forms and edit checks


• Provides data management leadership and strategic input at the Clinical Subteam and Study Team Meetings for all areas relating to data management including the overall data collection plan, and risk-based monitoring


• Identify areas of risk and proactively communicate issues and solutions (risk mitigation) to management and to the appropriate team members


• Manage in-house and CRO resources of assigned projects (RFT, FSP, and contractors) and identify potential deficiencies or timeline conflicts; provide potential solutions to Head of Clinical Data Management and implement a plan to overcome any obstacles


• Serve as the Clinical Data Management Lead on one or more studies and performs hands‑on clinical data management tasks to support clinical studies, including, but not limited to the following: reviewing protocols, designing eCRFs, performing UAT, documenting edit check specs, QC'ing external data, reviewing eCRF data, running SAS datasets, coding MH, AE, and CM data, and ensuring database lock activities are completed


• Serve as a lead contributor for data management‑related NDA submission activities, as appropriate


• Respond to questions and findings from QA audits