3 дня назад
Senior Clinical Data Manager (Clinical Data Management)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Data Manager (Clinical Data Management): Leading clinical data management for global clinical trials from study start-up through database lock with an accent on EDC builds, data review, reconciliation, vendor oversight, and regulatory-compliant delivery. Focus on leading complex studies, applying CDISC and ICH-GCP standards, mitigating data risks, and coordinating sponsors and cross-functional teams.
Location: Remote or office-based in Johannesburg, Reading, Swansea, or Livingston
Company
Strategic Solutions is a sponsor-dedicated clinical research organization supporting global clinical trials and the development of treatments.
What you will do
- Serve as the primary data lead within cross-functional study teams and sponsor partnerships.
- Drive study start-up activities, including EDC builds, system integrations, UAT, and data management deliverables.
- Oversee data review, reconciliation, vendor management, and database lock activities.
- Ensure compliance with CDISC standards, ICH-GCP requirements, and regulatory expectations.
- Identify and mitigate risks while improving operational processes and data delivery quality.
Requirements
- Bachelor’s degree in Life Sciences, Health Sciences, or a related discipline.
- 6+ years of Clinical Data Management or Clinical Data Science experience in a CRO or pharmaceutical environment.
- Experience leading studies across the full clinical trial lifecycle and acting as a primary Data Lead on complex studies.
- Hands-on experience reviewing and reconciling EDC, vendor, eCOA, IRT, and SAE data.
- Experience with EDC systems; Veeva EDC is preferred.
- Knowledge of CDISC, including SDTM, clinical trial processes, regulatory requirements, and ICH-GCP, plus strong communication, problem-solving, and project leadership skills.
Culture & Benefits
- Collaborative environment within a sponsor-dedicated operating model.
- Annual leave entitlements and country-specific benefits.
- Health insurance options for employees and families.
- Retirement planning, life assurance, and employee assistance support.
- Additional optional benefits may include childcare vouchers, bike purchase schemes, gym memberships, travel subsidies, and health assessments.
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