sumit jaiswar

Manage and maintain accurate study-level progress information.
Coordinate with Contract Research Organizations (CROs) and vendors to ensure compliance with contracted scopes of work.
Track and report on study progress, ensuring timely updates for stakeholders.
Develop and maintain essential study documentation to support best practices.

Conduct centralized monitoring of patient specimen management and laboratory analyses.
Collaborate with internal departments to ensure project milestones are met.
Communicate issues impacting timelines to project management promptly.
Train and mentor new employees, implementing improvements in workflows.

Ensure security and efficient retrieval of proprietary and client data.
Maintain logs and metadata in databases for accurate tracking and retrieval.
Provide reference services to internal clients in compliance with Standard Operating Procedures (SOPs) .
Coordinate workflow and manage report collection and validation processes.

• Conduct ICH-GCP guideline training for site staff.
• Assist investigators with patient screening, informed consent, and sample management.
• Oversee investigational product dispensing and ensure drug accountability.
• Maintain study files to ensure compliance with SOPs and project timelines.
• Preparing and submitting regulatory and ethics committee (EC) dossiers.
• Managed Informed Consent Forms (ICF) and ensuring compliance with ethical standards.