Principal Specialist, Clinical Data Management

Neurocrine Biosciencesis 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 companys diverse portfolio includes FDA-approved treatments for tardive dyskinesia chorea associated with Huntingtons 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 and follow the company onLinkedInX Facebook and YouTube. (*in collaboration with AbbVie)

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.

• Leads performs and oversees data management activities for clinical studies and/or clinical programs

• 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 QCing 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

• Masters 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

• Proficiency with Word Excel and PowerPoint is required

• Thorough understanding of the drug development process

• Proficiency with Medidata Rave is required

• Knowledge of other programming languages is a plus

• Familiarity with Business Objects and SAS is helpful

• Strong 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

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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 dont line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $130800.00-$179000.00. Individual pay decisions depend on various factors such as primary work location complexity and responsibility of role job duties/requirements and relevant experience and 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.