5 дней назад
External Data Specialist (Contract) (Clinical Data Management)
85 000 - 110 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
External Data Specialist (Clinical Data Management): Processing and validating external and local laboratory data throughout clinical trials with an accent on data integrity, laboratory normal ranges, vendor data transfers, and clinical database alignment. Focus on reviewing protocols and eCRF designs, performing quality control and reconciliation, building exception listings, and identifying data risks through clinical data analytics.
Location: Remote
Salary: $85,000–$110,000 USD annually
Company
provides clinical data services and the elluminate Clinical Data Cloud to help life sciences organizations manage clinical trial data and analytics.
What you will do
- Process external and local laboratory data throughout the clinical trial lifecycle while maintaining data integrity and compliance with departmental procedures.
- Review study protocols, local laboratory and external data eCRF designs, and data management documentation.
- Perform quality control of laboratory normal ranges, external data test transfers, vendor data listings, and clinical database alignment.
- Maintain reconciliation and change logs, verify links between laboratory normal ranges and patient results, and issue data queries.
- Develop exception listing specifications, visualizations, study metrics, and quality-controlled outputs for production.
- Collaborate with clinical data management, study teams, clients, vendors, and project management on data processes, reporting, and risk mitigation.
Requirements
- Bachelor’s degree in a health-related or basic science field, or equivalent education, training, and directly related experience.
- Excellent command of written and spoken English.
- Understanding of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, and medical terminology.
- Knowledge of clinical data management processes and vendor data processing.
- Ability to maintain data confidentiality, manage multiple projects independently, and work effectively with cross-functional teams.
- Strong attention to detail, organization, multitasking, and communication skills.
Nice to have
- Medical Laboratory Technology certificate.
- Experience supporting local laboratory and external vendor data processes.
Culture & Benefits
- Remote work arrangement.
- Opportunity to work on clinical data and analytics technologies supporting life sciences programs.
- People-first culture focused on inclusion, learning, growth, and continuous improvement.
- Recognition for workplace culture, vision, and work-life balance.
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