8 дней 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): Leading clinical data management across global trials from study start-up through database lock with an accent on EDC builds, data review, reconciliation, vendor oversight, and regulatory compliance. Focus on coordinating cross-functional sponsor teams, managing complex clinical data sources, and ensuring CDISC and ICH-GCP requirements are met.
Location: Remote or office work available from Warsaw, Johannesburg, Reading, Swansea, or Livingston
Company
is a healthcare intelligence and clinical research organization providing clinical development services and client-dedicated study teams.
What you will do
- Act as the primary data lead for cross-functional clinical study teams and sponsor partnerships.
- Drive study start-up activities, including EDC build, system integrations, UAT, and data management deliverables.
- Oversee data review, reconciliation, vendor management, and database lock activities.
- Manage data from EDC, vendor, eCOA, IRT, and SAE systems across the clinical trial lifecycle.
- Identify and mitigate operational risks while improving data management processes.
- Ensure high-quality, regulatory-compliant clinical data delivery.
Requirements
- Bachelor’s degree in Life Sciences, Health Sciences, or a related discipline.
- 6+ years of experience in Clinical Data Management or Clinical Data Science within a CRO or pharmaceutical environment.
- Experience leading studies throughout the full clinical trial lifecycle.
- Experience serving as a primary Data Lead on complex studies or extensive hands-on data review and reconciliation experience.
- Hands-on experience with EDC systems; Veeva EDC experience is preferred.
- Knowledge of CDISC standards, including SDTM, clinical trial processes, regulatory requirements, and ICH-GCP.
Nice to have
- Experience with Veeva EDC.
- Extensive experience managing complex studies and multiple clinical data sources.
Culture & Benefits
- Inclusive workplace focused on belonging, accessibility, and equal opportunity.
- Country-specific annual leave and health insurance options.
- Retirement planning offerings and life assurance.
- Global Employee Assistance Programme with 24-hour access to professional support.
- Optional benefits may include childcare vouchers, bike purchase schemes, gym discounts, travel subsidies, and health assessments.
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