обновлено 3 дня назад
Senior Data Manager Consultant (Clinical Research)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Data Manager Consultant (Clinical Research): Leading data management activities for clinical trials, including database setup, study conduct, and close-out with an accent on eCRF specifications and data validation plans. Focus on ensuring study deliverables meet strict regulatory quality standards and managing database locks for statistical review.
Location: United States
Company
A global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, and medical device companies.
What you will do
- Lead data management activities to ensure study deliverables meet timelines and quality standards.
- Review clinical research documents and create electronic Case Report Form (eCRF) specifications.
- Develop critical DM documents including the Data Management Plan, Data Validation Plan, and Data Review Plan.
- Develop edit rules, query logic, and perform User Acceptance Testing (UAT) on data entry screens.
- Perform ongoing data review, reconciliation, and manage database lock/unlock activities.
- Coordinate the archiving of study databases and perform SAE reconciliation.
Requirements
- Bachelor’s degree in clinical, pharmacy, biological, mathematical sciences, nursing, or a related field.
- At least 3 years of data management experience within the pharmaceutical industry.
- Strong knowledge of clinical research processes and related regulatory requirements.
- Experience with EDC systems such as Medidata Rave, Oracle InForm, OpenClinica, or Medrio.
- Ability to perform duties in compliance with SOPs, GCP, and ICH guidelines.
- Excellent verbal and written communication skills.
Culture & Benefits
- Supportive culture with a strong focus on quality and professional development.
- Opportunity to work directly for a single sponsor with the security of a global CRO.
- Inclusive environment celebrating diversity across gender, race, and ethnicity.
- Continuous training programs to maintain high levels of competence and expertise.
- Low industry-average turnover rates due to a strong company ethos.
Hiring process
- Initial CV submission and acknowledgment.
- Phone interview for candidates meeting the requirements.
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