Tasks:
- * Coordinate audits, inspections, deviations, and corrective actions
- * Coordinate study deliverables with cross functional teams
- * Develop data handling and data review plans
- * Ensure regulatory compliance and data quality
- * Generate data listings and study status reports
- * Identify and resolve protocol issues affecting database design, validation, and analysis
- * Lead data management across assigned clinical trials
- * Lead synonym reviews and dictionary version upgrades
- * Manage study start-up data management activities
- * Manage trial-level data management documentation and standards
- * Perform user acceptance testing
- * Reconcile serious adverse event data
- * Review clinical, third-party, and laboratory data
- * Review protocols and amendments for data management impact
- * Set up local laboratories in clinical databases
- * Train and support junior staff
Perks/Benefits:
Skills/Tech stack required:
[Acceptance Testing] [Audit and Inspection] [Audit and inspection readiness] [Clinical data] [Clinical Database] [Clinical database management] [Clinical data management] [Clinical data review] [Clinical trial] [Clinical trial management] [Corrective and Preventive Action] [Data Analysis] [Database Design] [Database Management] [Data Governance] [Data handling] [Data Handling Plans] [Data Integrity] [Data Listings] [Data Management] [Data Quality] [Data reporting] [Data review] [Data review plans] [Data Standards] [Data Validation] [Dictionary Management] [Graphical User Interfaces] [Inspection Readiness] [Laboratory data] [Laboratory data management] [Medical Dictionary] [Medical Dictionary Management] [Preventive Action] [Programming] [Serious Adverse Event] [Serious Adverse Event Reconciliation] [Trial management] [User Acceptance] [User Acceptance Testing] [User Interfaces] [Waterfall model]
Educational requirements:
N/A
Role(s):
[Clinical Data Manager] [Clinical Data Scientist] [Data Manager] [Data Scientist] [Manager] [Scientist] [Senior Clinical Data Scientist] [Trial Data Manager]