Adhere to all applicable Standard Operating Procedures (SOPs) and Work Instructions relevant to departmental and study-specific activities.
Daily Operations
Perform day-to-day operational tasks , ensuring adherence to quality standards and maintaining productivity levels.
Metrics Tracking
Track and report metrics as defined by management within required timelines.
Process Improvement
Participate in process improvement initiatives , assisting with the implementation of revised processes and procedures to enhance efficiency and compliance.
Study Management Support
Manage clinical systems and oversee access management for study tools and platforms.
Handle and maintain study documents , supporting electronic Trial Master File (eTMF) management.
Maintain and update study databases (e.g., CTMS , IWRS , EDC ).
Assist the study team with data review and other support activities .
Track and follow up with Clinical Research Associates (CRAs) regarding outstanding issues.
Generate study-specific reports to support decision-making and monitoring.
Manage internal and external communications to ensure alignment among stakeholders.
Ensure training compliance for all study team members.
Oversee study payments for clinical sites and vendors, ensuring accuracy and timeliness.
Skills Required
ctms, EDC, Sops
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Senior • Bengaluru / Bangalore
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