4 часа назад
Associate Director, External Data Acquisition and Delivery (Clinical Data)
154 800 - 252 800$
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, External Data Acquisition and Delivery (Clinical Data): Leading external data acquisition, integration, reconciliation, quality oversight, and delivery across a clinical trial portfolio with an accent on vendor governance, data conformance, and regulatory compliance. Focus on managing complex clinical data discrepancies, driving automation and process improvements, and developing an external data delivery team.
Location: Warren, New Jersey, United States; hybrid with 4 days per week onsite. Travel may be required up to 25%.
Salary: $154,800–$252,800 annually
Company
is a biotechnology company that discovers, develops, and commercializes medicines for serious diseases.
What you will do
- Lead external data acquisition, integration, quality oversight, reconciliation, and delivery strategy across clinical trials.
- Review protocol requirements, vendor specifications, operational data flows, and Data Transfer Specification documents.
- Oversee external vendors, including onboarding, qualification, governance, performance monitoring, KPIs, SLAs, and quality metrics.
- Govern reconciliation between EDC systems and vendor platforms, monitoring discrepancies, trends, and resolution timelines.
- Drive process improvements, automation opportunities, and innovative external data solutions.
- Manage, coach, mentor, and develop EDAD Managers, Specialists, and associates.
Requirements
- 10+ years of experience in clinical data acquisition or management within biotechnology, pharmaceutical, or healthcare industries.
- 4+ years of people management experience and demonstrated leadership of external data reconciliation activities.
- Expertise with clinical external data types including biomarker, imaging, eCOA, ECG, PK, genomics, laboratory, and Digital Health Technology data.
- Advanced knowledge of EDC platforms such as Medidata Rave, Veeva, or Oracle Inform, plus SAS, CSV, and XML data formats.
- Understanding of 21 CFR Part 11, ICH-GCP, and CDISC standards.
- Bachelor’s degree in science, health, mathematics, computing, information systems, or a related field; an advanced degree is preferred.
Nice to have
- Advanced degree in a relevant discipline.
Culture & Benefits
- Science-driven work focused on developing life-changing medicines for serious diseases.
- Fast-paced, matrixed, and global working environment.
- Comprehensive rewards may include bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
- Inclusive workplace with reasonable accommodation available during recruitment where required.
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