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Boston, Massachusetts, United States
Remote only
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)
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Leads, performs, and oversees data management activities for clinical studies and/or clinical programs
Experience leading and supporting First-In-Human (FIH) clinical studies, including early protocol review, eCRF and database design, and alignment with dose-escalation and safety objectives
Hands-on management of data management activities for FIH studies, with emphasis on rapid data cleaning, near real-time safety data review, and support for frequent interim analyses
Close collaboration with Clinical Operations, Safety, and Biostatistics teams to support timely decision-making and governance in FIH studies
Performs hands-on clinical data management tasks to support clinical studies, including, but not limited to: reviewing study protocols, designing eCRFs, performing and coordinating user acceptance testing (UAT), documenting edit check specifications, QC’ing external data transfers, performing data quality checks/discrepancy review, and ensuring database lock activities are completed
Participate in, review, and lead development of policies, Standard Operating Procedures (SOPs), processes, and associated documents for data management; provide input on SOPs and processes in which data management is involved
Promote/advocate data management at inter- and intradepartmental meetings
Provide technical expertise to staff within Data Management, Biometrics, and other NBI departments; develop and execute training, including project-specific training, as necessary
Assist with responding to questions and findings from QA audits; ensure responses to Corrective Action Forms (CAFs) are closed out appropriately
Actively research current industry trends and share information with appropriate individuals at NBI
Recommend improvements to existing data management practices and procedures, including identifying, recommending, and implementing solutions for technology issues
Assist in the development of standardized documents within data management (both within and across projects/programs), including electronic case report forms and edit checks
Oversee screening, selection, validation, and implementation of data management software purchases and upgrades
Participate in selecting outsourcing vendors and review data management sections of proposals, including scope of work; monitor budgets as appropriate
Coordinate data management timelines for individual projects and well as clinical programs, including database lock, DSMB meetings, data review meetings, and monitoring CRO performance of data management tasks to ensure that timelines are met and that any resource issues are identified and resolved
Monitor in-house resources of assigned projects and identify potential deficiencies; work with supervisor to develop and implement a plan to overcome any obstacles
Ensure that appropriate quality control checks and audit procedures are implemented according to department SOPs
Run data review listings, issue queries, code Medical History and AE data using MedDRA dictionary and code Concomitant Medications using WHO Drug dictionary
Collaborate with database programmer to ensure NBI database standards, including CDISC/SDTM, are followed for both in-house and, if appropriate, outsourced projects
Identify areas of risk and proactively communicate issues and solutions to supervisor and/or appropriate colleagues and team members
Actively participate in data management-related NDA submission activities, as appropriate
Provide feedback, as requested, for performance evaluations. Identify strengths and areas for improvement for DM team members and work with supervisor to create a plan to develop team members
Perform other duties as assigned
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
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
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
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
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Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of 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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The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.