Job title: Principal Clinical Data Manager- San Diego based
Company: Neurocrine Biosciences
Job description: Who We Are:At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose – to relieve suffering for people with great needs, but few options.What We Do:Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, 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 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 , and follow the company on , and . (*in collaboration with AbbVie)About the Role: Leads, performs, and oversees data management activities for assigned clinical studies for both in-house and outsourced clinical trial data; evaluates, develops, and implements data management processes, procedures, and tools to ensure business requirements are met; collaborates within Biometrics and with Medical, DSPV, Regulatory, QC, and other internal customers to ensure high quality data in support of regulatory submissions, safety reporting, and publications._Your Contributions (include, but are not limited to):Leads, performs, and oversees data management activities for clinical studies and/or clinical programsPerforms 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 completedParticipate 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 involvedPromote/advocate data management at inter- and intradepartmental meetingsProvide technical expertise to staff within Data Management, Biometrics, and other NBI departments; develop and execute training, including project-specific training, as necessaryAssist with responding to questions and findings from QA audits; ensure responses to Corrective Action Forms (CAFs) are closed out appropriatelyActively research current industry trends and share information with appropriate individuals at NBIRecommend improvements to existing data management practices and procedures, including identifying, recommending, and implementing solutions for technology issuesAssist in the development of standardized documents within data management (both within and across projects/programs), including electronic case report forms and edit checksOversee screening, selection, validation, and implementation of data management software purchases and upgradesParticipate in selecting outsourcing vendors and review data management sections of proposals, including scope of work; monitor budgets as appropriateCoordinate 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 resolvedMonitor in-house resources of assigned projects and identify potential deficiencies; work with supervisor to develop and implement a plan to overcome any obstaclesEnsure that appropriate quality control checks and audit procedures are implemented according to department SOPsRun data review listings, issue queries, code Medical History and AE data using MedDRA dictionary and code Concomitant Medications using WHO Drug dictionaryCollaborate with database programmer to ensure NBI database standards, including CDISC/SDTM, are followed for both in-house and, if appropriate, outsourced projectsIdentify areas of risk and proactively communicate issues and solutions to supervisor and/or appropriate colleagues and team membersActively participate in data management-related NDA submission activities, as appropriateProvide 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 membersPerform other duties as assignedRequirements: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) ORMaster’s degree in computer science or a related discipline and 6+ years of similar experience noted above ORPhD in computer science or a related discipline and 4+ years of similar experience noted above3+ years of experience serving in a supervisory or lead capacityProficiency with Word, Excel, and PowerPoint is requiredThorough understanding of the drug development processProficiency with Medidata Rave is requiredKnowledge of other programming languages is a plusFamiliarity with Business Objects and SAS is helpfulStrong knowledge of Good Clinical Data Management Practices, CDISC/CDASH/SDTM and other FDA and industry-standard guidelines is required.Demonstrated proficiency in effectively overseeing/managing people (indirectly or directly) and organizing tasks is necessary.Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplinesWorks to improve tools and processes within functional areaAbility to work as part of and lead multiple teamsExhibits leadership skill and ability, typically leads lower levels and/or indirect teamsExcellent computer skillsExcellent communication, problem-solving, analytical thinking skillsSees broader picture, impact on multiple departments/divisionsAbility to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiencyExcellent project management skills#LI-TM1Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.We are committed to building a diverse, equitable, and inclusive workplace, 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._ The annual base salary we reasonably expect to pay is $125,700.00-$182,250.00. 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.
Expected salary: $125700 – 182250 per year
Location: San Diego, CA
Job date: Sat, 21 Sep 2024 00:26:05 GMT
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