Sateesh Kumar Email & Phone Number

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Bangalore

Perform ongoing remote data review, assess for completeness of data and any observed protocol or GCP deviations/violations.Perform event-triggered real-time data review and review of key risk, performance, and quality indicators (KRIs, KPIs, KQIs). Issue queries based on remote data review.Track and assess trending of violations/deviations, enrollment.

Bangalore

Ensured effective security, storage and retrieval of all proprietary and client information in accordance with established procedures.Provided reference services to internal clients in accordance to SOPs and by maintaining accurate charge-out systems like ELVIS, EEL and Center File for the purpose of filing regulatory documents filing in eTMF. Performed.

Visakhapatnam, India

• As a clinical reseach manager coordinated site management and ensured to conduct clinical trila as per ICH-GCP to strictly adhere the project delverible timelines provided by SponsorPerformed in House monitoring, SIV.
• Communicated with the Sponsor, Ethics Committee and updated the Principal Investigator about the status quo and trial related events.
• Trained all research staff including Investigators, delegated coodinators trained on protocol and provided udpates monthly.
• Work shops conducted on on ICH-GCP, Quality assurance and overview of Clinical trials
• Managed and assisted coordinators to adhere protocol and GCP. Conducted over view on all the activities done by the delegated research staff
• Assited Principal Investigators to communicated EC and Regulatory authorities promptly.

Government Hospital For Mental Care, Visakhapatnam

• Worked as a CRC in several Neuro Psychiatry Clinical Trials across Sponsors in different phases and had experience in FDA Inspection, Indian Regulatory (DCGI), Local Ethics Committee, Independent Audit, Sponsor QA and.
• Communicated with the Sponsor, Ethics Committee and updated the Principal Investigator about the status quo and trial related events.
• Coordinated site management and clinical activities as per ICH-GCP.
• Coordinated and remind subject for all site visits which adhered to protocol requirement.
• Reminded and ensured that the sub-investigator completes all trial related procedures and evaluations as per the protocol.
• Collected and maintained documents in Investigator Site File updated on a routine.

KGH, Dept.Neurology

• Coordinated site management and clinical activities as per ICH-GCP.
• Coordinated and remind subject for all site visits which adhered to protocol requirement.
• Reminded and ensured that the sub-investigator completes all trial related procedures and evaluations as per the protocol.
• Collected and maintained documents in Investigator Site File updated on a routine.
• Ensured monitoring activity were performed and followed up in compliance with SOP.
• Coordinated to keep the site and source files audit ready.

Master Of Business Administration - Mba, Operations Management And Supervision

Master Of Science (M.Sc.), Organic Chemistry, 72%

Bsc, Andhra University