Principal Specialist, Clinical Data Management

Neurocrine Biosciences • San Diego, CA

1d

About The Position

The Principal Analyst, Clinical Data Management is responsible for overseeing the clinical database programming function within Clinical Data Management for all Neurocrine studies.

Requirements

• BS/BA degree in computer science or a related discipline AND 8+ years of experience in the Pharmaceutical Industry, (either in-house/sponsor or CRO). OR Master’s degree in computer science or a related discipline AND 6+ years of similar experience noted above OR PhD in computer science or a related discipline AND 4+ years of similar experience noted above OR 3+ years of experience serving in a supervisory or lead capacity
• 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
• Ability to work as part of and lead multiple teams
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
• Excellent computer skills
• Excellent communication, 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
• Qualified candidate must have a thorough understanding of the drug development process
• Experience working with GCP and 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

Nice To Haves

• Experience with Business Objects, Rave Targeted SDV and Batch Uploader preferred
• Experience with C# programming (custom functions) is a plus
• Ability to communicate effectively both verbally and in writing

Responsibilities

• 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
• 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 within the clinical data management group, within and outside of Biometrics; 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)
• Research and recommend use of new technology to streamline data collection, validation, and review

Benefits

• annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program
• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 501-1,000 employees