MANAGER, CLINICAL DATA SYSTEMS
The Manager, Clinical Data Systems is responsible for overseeing the clinical database programming function within Clinical Data Management and within Clinical Drug Safety (as needed) for all Neurocrine studies.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to:
- Hire, train, supervise, evaluate, and mentor/develop clinical database programmers in order to support the creation and maintenance of clinical study databases for all corporate therapeutic program areas
- Work with head of Data Management and project team to develop and monitor database-related timelines such as database set-up, validation procedure programming, and timing of batch data transfers
- Assess workload and projects in order to ensure appropriate resources are available to complete tasks per timelines
- Evaluate current processes; set standards and ensure consistency within and across programs and studies
- Set priorities and ensure alignment with company objectives
- Oversee quality of work performed and ensure it meets Neurocrine-defined standards
- Oversee electronic data loading (set specifications with external vendors, monitor timelines, load data); update/install new coding dictionary versions; actively participate in installation, validation and implementation of new software
- Develop required SOPs and work instructions as well as Data Management Plan documents; ensure processes are followed and all work is documented per SOPs
- Ensure process efficiency, proactively identify any gaps, and work with staff to implement alternative processes as necessary
- Analyze problems of high complexity; develop and implement alternative solutions both internally and with vendors; proactively identify areas of inconsistency and processes for potential improvement
- Serve as the expert resource for clinical database programming both within and outside the clinical data management group (eg, Clinical Drug Safety); acts as a liaison between Clinical Data Management and project teams as needed
- Perform clinical database programming tasks, including, but not limited to, creating programs/reports to support data review and cleaning; building Medidata Rave EDC databases; programming validation/derivation procedures and database audit listings; performing database migrations; setting up Targeted SDV configuration; creating SAS datasets; maintaining database Global Library
- Manage contractors/consultants as well as CRO (if appropriate)
- Provide input for department budget for clinical database programming needs
- Research and recommend use of new technology to streamline data collection, validation, and review
- Perform other related duties as assigned
Qualified candidate must have a thorough understanding of the drug development process as well as experience working with GCPs/ CDISC/CDASH/SDTM standards, developing SOPs/Work Instructions, and following required FDA guidance documents. Must have hands-on clinical database programming skills, including SAS, SQL, and Medidata Rave Architect as well as the ability to effectively handle multiple projects and priorities simultaneously. Experience with Business Objects, Rave Targeted SDV and Batch Uploader preferred. Experience with C# programming (custom functions) is a plus. Proficiency with Word, Excel, and Powerpoint is required as is the ability to communicate effectively both verbally and in writing. Requires the ability to sit or stand while working on a computer for a long period of time. Must be willing to travel up to 5% per year.
EDUCATION and/or EXPERIENCE:
Bachelor’s degree (or equivalent experience) in computer science or a related discipline with a minimum of eight years of experience in the biopharmaceutical (or CRO) industry, including clinical database programming experience using Medidata Rave. In addition, candidate must have at least three years of experience serving in a supervisory or lead capacity.