data sciencegcpsasclinical trialsedcichclinical data managementecrfedit checks
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Текст:
Hirify AI/Оригинал
TL;DR
Senior Clinical Data Science Lead (Clinical Data Management/Clinical Trials): Leading clinical data management workstreams from study start-up through clean database declaration with an accent on eCRF and metadata specifications, data cleaning, EDC collaboration, and cross-functional study delivery. Focus on interpreting clinical protocols and analysis plans, coordinating edit checks and database closure, and resolving complex data quality and timeline issues.
Location: Remote in the UK or South Africa; locations listed as Reading and Johannesburg
Company
hirify.global Strategic Solutions provides sponsor-dedicated clinical development and clinical data management services through global sponsor partnerships.
What you will do
Lead Clinical Data Management activities from study start-up through database closure and clean database declaration.
Oversee, guide, mentor and train Data Management colleagues assigned to study protocols.
Develop and maintain eCRFs, study metadata, edit checks, Data Validation Documents and protocol deviation documentation.
Collaborate with EDC developers on eCRF and database design and contribute to EDC User Acceptance Testing.
Manage data cleaning, queries, consistency checks, listings and extracts for medical review, reporting and cross-functional activities.
Coordinate SAS programming requirements, data monitoring activities, database closure plans and issue resolution across global study teams.
Requirements
Bachelor’s degree or equivalent in Natural Sciences, Informatics, Medical Documentation or a related discipline.
5+ years of experience as a Clinical Data Manager, with significant responsibility within clinical projects and study teams.
Strong understanding of the drug development process, clinical data management methodologies and technologies, and clinical development IT processes and databases.
Experience managing clinical data from study start-up through clean database declaration and working toward First Patient First Visit readiness and timely database closure.
Experience interpreting Clinical Study Protocols, Statistical Analysis Plans and Medical Review Plans and translating them into data management specifications.
Experience working in global, cross-functional teams with Study Management, Medical, EDC Development, Statistics and Medical Writing.
Good understanding of relevant clinical research regulations and guidelines, including ICH and GCP.
Experience training or mentoring junior Data Management colleagues, providing guidance and acting as an escalation point.
Strong project management, organisational, self-management, written and verbal communication skills, with the ability to work independently and manage priorities.
Fluent spoken English and strong local-language communication skills are required.
Proactive commitment to continuous learning and professional development.
Culture & Benefits
Sponsor-dedicated work supported by hirify.global’s global expertise, with a collaborative environment and career development opportunities.
Annual leave entitlements and country-specific health insurance options.
Retirement planning offerings, life assurance and a global employee assistance programme.
Flexible country-specific benefits may include childcare vouchers, bike purchase schemes, gym memberships, travel passes and health assessments.
Inclusive workplace committed to equal consideration, accessibility and reasonable accommodations.
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