8 дней назад
Lead Data Manager (Clinical Data Management)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Lead Data Manager (Clinical Data Management): Leading clinical data management start-up activities for clinical trials from protocol review and study build specifications through testing, validation, and database go-live with an accent on CDISC standards, eCRF design, and cross-functional delivery. Focus on translating protocol requirements into compliant study configurations, coordinating UAT and defect resolution, and managing amendments, risks, and documentation under ICH-GCP and regulatory standards.
Location: Remote from Sofia, Dublin, Warsaw, Barcelona, or Reading
Company
Strategic Solutions provides sponsor-dedicated clinical research services through a global full-service provider model.
What you will do
- Lead end-to-end clinical data management start-up activities from protocol review and specification development through database build, testing, validation, and production go-live.
- Translate protocol requirements into study build specifications covering visit schedules, assessments, eCRFs, dosing, data collection, and edit checks.
- Apply CDISC standards, eCRF design principles, field and variable conventions, and approved standard forms.
- Coordinate with Study Execution Teams, Medical Data Review, Programming, Data Management, Standards, and other stakeholders to resolve requirements and configuration issues.
- Plan and oversee sandbox testing and UAT, including defect documentation, issue resolution, retesting, and system-readiness confirmation.
- Manage timelines, dependencies, risks, protocol amendments, post-go-live changes, and start-up documentation in the eTMF.
Requirements
- Bachelor’s degree in life sciences, computer science, or a related discipline.
- Extensive experience in data analysis and project leadership within a clinical research setting.
- Strong expertise in statistical software and data visualization techniques.
- Exceptional analytical and problem-solving skills, with the ability to translate data into actionable insights.
- Excellent communication and leadership skills for collaboration across diverse teams.
- Willingness to travel approximately 15% as required.
Culture & Benefits
- Remote working arrangement tied to the listed European locations.
- Annual leave entitlements and country-specific health insurance options.
- Retirement planning offerings and life assurance.
- Global Employee Assistance Programme with 24-hour access to specialized wellbeing support.
- Optional benefits may include childcare vouchers, bike purchase schemes, gym memberships, travel passes, and health assessments.
- Inclusive workplace focused on diversity, accessibility, wellbeing, and work-life balance.
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