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6 дней назад

Senior Clinical Data Science Lead

Формат работы
remote (только Europe)
Тип работы
fulltime
Грейд
senior/lead
Английский
b2
Страна
UK/SA
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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 developing CRFs, metadata, protocol deviation documents and edit check 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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