Principal Specialist, Clinical Data Management

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $130.8k - $179k / year

⏰ Full Time

🔴 Lead

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Neurocrine Biosciences

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

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.

📋 Description

• Lead, perform, and oversee data management activities for assigned clinical studies and programs • Lead and support First-In-Human clinical studies, including protocol review, eCRF and database design, and alignment with dose-escalation and safety objectives • Manage FIH data activities with rapid data cleaning, near-real-time safety data review, and frequent interim analyses • Collaborate with Clinical Operations, Safety, Biostatistics, Medical, DSPV, Regulatory, QC, and other internal teams • Review protocols, design eCRFs, coordinate user acceptance testing, document edit-check specifications, QC external data transfers, perform data quality checks and discrepancy reviews, and complete database locks • Develop and review policies, SOPs, processes, and associated data management documents • Provide technical expertise and training to Data Management, Biometrics, and other departments • Respond to QA audit questions and findings and ensure Corrective Action Forms are appropriately closed • Research industry trends and recommend improvements to data management practices, procedures, and technology • Develop standardized data management documents, eCRFs, and edit checks • Oversee selection, validation, and implementation of data management software purchases and upgrades • Select outsourcing vendors, review proposal data management sections and scopes of work, and monitor budgets • Coordinate project and program timelines, including database locks, DSMB meetings, data review meetings, and CRO performance • Monitor project resources, identify deficiencies, and resolve obstacles with the supervisor • Implement quality control checks and audit procedures according to department SOPs • Run data review listings, issue queries, and code Medical History, adverse event, and concomitant medication data using MedDRA and WHO Drug dictionaries • Ensure NBI database standards, including CDISC/SDTM, are followed • Identify risks and communicate issues and solutions • Participate in data management-related NDA submission activities • Provide performance feedback and support development plans for Data Management team members

🎯 Requirements

• BS/BA degree in computer science or a related discipline and 8+ years of experience in the pharmaceutical industry; or Master’s degree and 6+ years of similar experience; or PhD and 4+ years of similar experience • 3+ years of experience serving in a supervisory or lead capacity • Thorough understanding of the drug development process • Experience working with GCP and CDISC/CDASH/SDTM standards • Experience developing SOPs/Work Instructions and following required FDA guidance documents • 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 for custom functions is a plus • Ability to communicate effectively verbally and in writing • Knowledge of best practices in the functional discipline and familiarity with related business disciplines • Ability to improve tools and processes within the functional area • Ability to work as part of and lead multiple teams • Leadership ability, typically leading lower-level and/or indirect teams • Excellent computer skills • Excellent communication, problem-solving, and analytical-thinking skills • Ability to understand broader impact across departments and divisions • Ability to meet multiple deadlines across projects and programs with accuracy and efficiency • Excellent project management skills

🏖️ Benefits

• Annual bonus with a target of 30% of earned base salary • Eligibility to participate in equity-based long-term incentive program • Retirement savings plan with company match • Paid vacation • Paid holidays • Paid personal days • Paid caregiver/parental leave • Paid medical leave • Medical coverage • Prescription drug coverage • Dental coverage • Vision coverage