3 дня назад
Senior Clinical Data Manager
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Data Manager (Clinical Trials/Data Management): Managing clinical trial data processes from study start-up through post-database lock with an accent on database development, data quality, documentation, and stakeholder coordination. Focus on leading data management activities, conducting database testing and data review, overseeing edit checks and medical coding, and resolving operational issues across clinical studies.
Location: Remote in Hungary, Romania, Serbia, Slovakia, the United Kingdom, or Poland. Candidates must be legally authorized to work in the country of employment without employer sponsorship. Occasional travel may be required.
Company
operates a global clinical research organization supporting clinical trial and pharmaceutical, device, and biologic development programs.
What you will do
- Lead clinical data management activities for assigned clinical trial projects from study start-up through post-database lock.
- Oversee data entry processes, CRF specifications, database builds, user acceptance testing, edit checks, and database documentation.
- Review and query clinical trial data, perform line-listing and status reporting, and coordinate SAE/AE reconciliation.
- Perform medical coding and support data quality, consistency, and compliance with study plans, SOPs, work instructions, and regulatory requirements.
- Coordinate with sponsors, clinical research teams, external data and EDC vendors, and cross-functional stakeholders to manage timelines and deliverables.
- Identify operational issues, support process and SOP development, train project personnel, and provide leadership for data management initiatives.
Requirements
- Bachelor’s degree or an equivalent combination of relevant experience.
- 8+ years of experience as a Senior Clinical Data Manager or 5+ years as a Clinical Data Manager II in a clinical research organization, pharmaceutical, or biotech company.
- Experience with database setup and migrations, clinical database management systems, and clinical data management practices.
- Professional written and spoken English, with strong organizational, communication, leadership, and interpersonal skills.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
- Legal authorization to work in the country of employment without employer sponsorship.
Nice to have
- Oncology experience.
- Experience assisting with SAS programming and quality control of SAS programs.
- Experience reviewing protocols, Statistical Analysis Plans, and Clinical Study Reports.
Culture & Benefits
- Remote work arrangement within the listed European countries.
- Global collaboration with study sponsors, vendors, and cross-functional project teams.
- Opportunities to contribute to company-wide data management initiatives, training, and process documentation.
- Occasional travel may be part of the role.
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