Responsibilities:
- Collect enter and manage clinical trial data using electronic data capture (EDC) systems.
- Perform data validation and query management to ensure data quality and compliance with study protocols.
- Assist in the development of case report forms (CRFs) and data management plans (DMPs).
- Conduct ongoing data review and discrepancy resolution in collaboration with clinical staff.
- Generate data listings and summaries for interim and final study reports.
- Ensure data handling is following GCP ICH guidelines and applicable regulatory requirements.
- Maintain study documentation audit trails and data queries logs.
- Participate in cross-functional study team meetings and contribute to project timelines.
Requirements:
- Bachelors degree in life sciences healthcare information technology or related field.
- 13 years of experience in clinical data management or a related clinical research role.
- Familiarity with EDC systems (e.g. Medidata Rave Oracle Clinical Redcap).
- Knowledge of GCP ICH and regulatory guidelines.
- Excellent attention to detail organizational and communication skills.
- Proficiency in Microsoft Excel and other data management tools.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract