Company Introduction
HRAPL operates within the pharmaceutical research domain, supporting structured clinical development programs through regulated project governance and study oversight.
Core Responsibilities
- Prepare and maintain clinical project plans using approved trial protocols, milestone trackers, and study management files.
- Review study progress through clinical trial management systems, monitoring visit schedules, site status logs, and enrollment trackers.
- Maintain trial documentation including study master files, vendor agreements, monitoring reports, and regulatory submission records.
- Oversee site readiness by reviewing initiation checklists, investigator meeting materials, and essential document completeness.
- Track study timelines using validated scheduling tools, ensuring alignment with protocol defined visit windows.
- Validate data flow by reviewing clinical data listings, query reports, and monitoring follow up records.
Skills and Technical Exposure
- Clinical Trial Management System platforms used for study tracking and site oversight.
- Electronic Trial Master File systems for document storage and inspection readiness.
- Regulatory submission dossiers including clinical study reports and investigator brochures.
- Clinical data review tools for listings, query review, and discrepancy tracking.
- Project scheduling software for milestone planning and dependency mapping.
Experience Context
- Work is performed within a clinical research corporate environment supporting multi site and global studies.
- Study scope includes multiple investigative sites, ongoing patient enrollment, and recurring monitoring cycles.
- Absence of this role results in delayed study milestones, incomplete documentation, and regulatory submission gaps.
How to Apply
Send resume to contact@hrapl.in
