5 дней назад
Data Manager (Clinical Trials)
85 - 105CAD
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Data Manager (Clinical Trials) (Clinical Data Management): Leading clinical trial data management from database setup through study close-out with an accent on electronic case report forms, validation plans, data review, and regulatory compliance. Focus on developing edit checks and query logic, coordinating reconciliation and database locks, and delivering high-quality clinical data within study timelines.
Location: Hybrid in Mississauga, Ontario, Canada
Salary: $85–$105 CAD
Company
is a global full-service contract research organization focused on clinical research services, professional development, work-life balance, and collaborative delivery.
What you will do
- Lead data management activities for clinical trials from database setup through study conduct and close-out.
- Review protocols, case report forms, and other clinical research documents; create and review electronic case report form specifications.
- Develop data management plans, validation plans, completion guidelines, data entry guidelines, and data review plans.
- Develop edit checks, query logic, query messages, and user acceptance testing plans; perform testing of data entry screens and edit checks.
- Conduct ongoing data review, reconciliation, SAE reconciliation, patient tracking, and data-cleanup monitoring.
- Coordinate database lock, unlock, freeze, unfreeze, archiving, data transfers, vendor reconciliation, and clinical team training.
Requirements
- Bachelor’s degree in clinical, pharmacy, biological, mathematical sciences, or a related field, or a nursing degree.
- At least 3 years of data management or related experience in the pharmaceutical industry.
- Working knowledge of clinical research, clinical trial processes, regulatory requirements, and related terminology.
- Strong experience with several electronic data capture systems, including Medidata Rave, Oracle InForm, OpenClinica, and Medrio.
- Ability to work in compliance with SOPs, GCP, and ICH guidelines and to lead a study or data management team independently.
- Excellent verbal and written communication skills and proficiency with Microsoft Office.
Culture & Benefits
- Permanent employment with a hybrid work arrangement.
- Collaborative one-team culture focused on quality and client satisfaction.
- Professional development opportunities and an emphasis on work-life balance.
- Inclusive, barrier-free recruitment and selection process with accommodation available for qualified applicants.
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