Description

You will manage clinical study documentation and database operations to ensure regulatory compliance and data integrity.

Responsibilities

• Maintain study documentation including CRFs, subject diaries, and annotated CRF specifications.
• Manage clinical databases using MediData Rave and Oracle Clinical according to DMP definitions.
• Analyze patient data, reconcile adverse events, and validate research results for business intelligence systems.
• Oversee data management activities and implement study-specific procedures to ensure regulatory compliance.
• Coordinate with internal departments and external vendors including CROs and laboratories.

Required Skills

• 5+ years of experience in clinical research or data management.
• Proficiency with MediData Rave and Oracle Clinical.
• Expertise in database management and Electronic Data Capture (EDC).
• Strong data analysis skills involving medical and financial record reconciliation.
• Experience with compliance and quality assurance protocols.
• Proven project management capabilities including timeline and budget oversight.
• Ability to develop systems for statistical data extraction and information distribution.
• Competency in system development to improve clinical operations workflows.

Preferred Skills

• Experience collaborating with Biostatistics, Drug Safety, and Pharmacovigilance teams.

Key Skills

Education

Any Graduate