Clinical Data Manager
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Clinical Data Manager (Clinical Data Management): Oversee clinical data management activities across database development, data cleaning, quality control, and database lock with an accent on CDISC compliance, regulatory requirements, and data quality. Focus on designing and maintaining eCRFs and clinical databases, leading sponsor/study communication, and supporting audits, inspections, and process improvements.
Location: Worldwide
Company
is a full-service, science-driven CRO providing clinical trial management and related services worldwide.
What you will do
- Lead clinical data management activities in compliance with CDISC standards, regulatory requirements, and SOPs.
- Design, validate, and maintain eCRFs, clinical databases, and related data management documentation.
- Perform data cleaning, coding, SAE reconciliation, quality checks, and database lock activities.
- Serve as the main point of contact for sponsors and study teams on data management matters.
- Track study milestones, manage deliverables, identify and escalate risks, and support audits and inspections.
- Mentor junior team members and contribute to study-specific training activities.
Requirements
- Bachelor’s degree in a scientific or related discipline.
- At least 7 years of clinical data management experience within a CRO, biotech, pharmaceutical company, or research organisation.
- Strong knowledge of CDISC standards, ICH-GCP, ISO14155, FDA 21 CFR Part 11, and clinical data management processes.
- Experience with clinical databases, eCRF systems, and data management tools.
- Excellent communication skills in English and ability to work effectively in international teams.
- Strong organisational skills, attention to detail, and a quality-focused mindset.
Culture & Benefits
- Competitive salary and additional benefits.
- Opportunity to grow within a collaborative and expanding international organisation.
- Work with cross-functional teams and sponsors across clinical development stages.
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