Sr. Manager, Clinical Data Management

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 andYouTube. (*in collaboration with AbbVie)

About the Role:

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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 (CAPA); ensure responses to Corrective Action Forms (CAFs) are closed out appropriately
• Perform other duties as assigned

Requirements:

• BS/BA degree AND 8+ years of relevant experience, or OR
• Masters AND 6+ years of related experience, or OR
• PhD AND 4+ years of related experience OR
• Previous managerial / functional management experience also required
• Requires broad understanding of the processes, procedures and systems used to accomplish the team’s work and familiarity with the underlying concepts in other disciplines within the function
• Applies in-depth understanding of how own discipline integrates within the function and understands contribution to Neurocrine's achievement of business objectives
• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
• Works to improve tools and processes within functional area
• Has reputation inside the company as it relates to area of expertise
• Ability to work as part of and lead multiple teams
• Strong leadership skills and abilities, manages teams.
• Excellent computer skills
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture, impact on multiple departments/divisions.
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Excellent project management skills
• Attention to detail and confidentiality are essential
• Proficiency with Word, Excel, and PowerPoint is required
• Thorough understanding of the drug development process
• Proficiency with Medidata Rave is required; knowledge of Rave Architect, Coder, eCOA, T-SDV, and Amendment Manager are a plus.
• Knowledge of other programming languages (including C# for custom functions) is a plus
• Proficiency with MedDRA and WHO Drug coding dictionaries
• Demonstrated expertise working on an NDA submission is required
• Working knowledge of Business Objects is a plus
• Proficiency with SAS is required
• Thorough knowledge of Good Clinical Data Management Practices, CDISC/CDASH/SDTM and other FDA and industry-standard guidelines (FDA and ICH regulations) is required
• Demonstrated proficiency in providing data management leadership and expertise from study protocol through data submission
• Experience in effectively overseeing/leading people (direct reports) and organizing tasks is required

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Neurocrine Biosciences is anEEO/Disability/Vets employer.

We are committed to building a workplaceof 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.

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