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11 дней назад

Clinical Data Manager

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
Australia
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
Clinical Data Manager (Clinical Trials/Data Management): Planning and delivering data management activities across clinical trials and investigations with an accent on CRF development, clinical databases, data cleaning, and regulatory compliance. Focus on validating study data, reconciling safety information, managing database locks, and coordinating deliverables with sponsors and study teams.

Location: Sydney, Australia

Company

hirify.global is an international science-driven biotech-focused CRO providing clinical trial management and related scientific, regulatory, pharmacovigilance, and technology services.

What you will do

  • Prepare and maintain Data Management Plans, CRFs, data transfer specifications, and other project documentation.
  • Design, develop, and validate paper and electronic CRFs and clinical databases.
  • Perform data cleaning, medical coding, SAE reconciliation, and quality control activities.
  • Manage database changes and support database freeze and lock activities.
  • Ensure compliance with applicable regulations and CDISC standards.
  • Collaborate with sponsors, study teams, and external stakeholders while monitoring milestones, KPIs, and deliverables.

Requirements

  • Bachelor’s degree in a relevant field.
  • At least 2 years of experience in a similar clinical data management role within a CRO, pharmaceutical company, biotech, or research institute is preferred.
  • Knowledge of clinical data management processes and applicable regulatory standards.
  • Excellent English communication skills, written and verbal.
  • Good knowledge of Microsoft Office and strong organizational, planning, and problem-solving skills.
  • Quality-driven, collaborative, flexible, and adaptable approach.

Nice to have

  • Familiarity with SAS.
  • Interest in innovation and expanding expertise in clinical data management.

Culture & Benefits

  • Competitive salary with additional benefits and bonuses.
  • Professional development opportunities.
  • Collaborative, quality-focused working environment.
  • Opportunity to contribute to international clinical research projects.

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