Sr. Manager, Clinical Data Management
Neurocrine Biosciences
Summary
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.
Job description
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 (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 Masters AND 6+ years of related experience, or PhD AND 4+ years of related experience
- 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
Benefits
- 401(k) Matching
- Paid Vacation
- Paid Holidays
- Paid Personal Days
- Paid Caregiver Leave
- Paid Parental Leave
- Paid Medical Leave
- Medical, Dental & Vision
- Prescription Drug Coverage
- Annual Bonus
- Equity Long-Term Incentive
Company overview
Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company founded in 1992 and headquartered in San Diego, California. The company specializes in discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Neurocrine's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids. Their flagship product, INGREZZA (valbenazine), was the first FDA-approved treatment for adults with tardive dyskinesia. The company maintains a robust pipeline with multiple compounds in mid- to late-phase clinical development across core therapeutic areas, including Parkinson's disease, Tourette syndrome, and major depressive disorder. Neurocrine operates with a purpose to relieve suffering for people with great needs, applying unique insights into neuroscience and the interconnections between brain and body systems to treat complex conditions. The company is publicly traded on NASDAQ under the symbol NBIX and has established strategic collaborations with major pharmaceutical partners including AbbVie.