11 часов назад
Principal Clinical Data Manager (Europe)
120 000 - 140 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Principal Clinical Data Manager (Clinical Data Management): Leading clinical data management strategies and oversight across the full data lifecycle for complex clinical trials with an accent on regulatory compliance, data quality, and cross-functional delivery. Focus on configuring elluminate for data cleaning, performing quality oversight and data trending, and developing technology-enabled process improvements.
Location: Remote in Europe
Salary: $120,000–$140,000 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
- Represent in sponsor data management interactions and ensure deliverables meet quality, scope, and timeline requirements.
- Provide subject matter expertise on clinical data management practices, technology, and solutions.
- Define study requirements covering protocol conversion, database builds, CRF design, data entry, verification, review, and query management.
- Define specifications and collaborate with technical teams to configure elluminate for data cleaning and oversight.
- Perform quality control on study documents, specifications, reports, deliverables, and elluminate modules.
- Analyze data trends, identify risks, develop mitigation strategies, and collaborate on process improvements and training.
Requirements
- Bachelor’s degree or higher in a relevant health science or scientific/technical discipline.
- 10+ years of experience in the pharmaceutical or biotechnology industry in clinical data management or an equivalent consulting role.
- Strong project management, team leadership, consulting, client relationship management, analytical, and strategic thinking skills.
- Excellent written and verbal English communication is required.
- Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, EDC, and clinical data management systems.
- Proficiency in Microsoft Office, especially MS Project and MS Excel; exposure to CDISC guidelines and standards.
Nice to have
- CCDM certification.
- Experience with Agile, Six Sigma, RBQM, cloud SaaS platforms, Qlik, JReview, or Spotfire.
- Master’s degree in science.
Culture & Benefits
- Remote work within Europe.
- People-first, inclusive culture focused on diversity and individual contribution.
- Opportunities for learning, growth, and continuous improvement.
- Recognition for work-life balance and remote work practices.
- AI tools may be used to improve productivity and quality while protecting confidential information and maintaining professional accountability.
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