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 status, and outstanding issues and escalate issues as necessary.Ensure study systems are updated per agreed study conventions (e.g., Clinical Trial Management System – CTMS) to ensure adequate communication to project team and sponsor. Liaise with CRA to prompt collection of documents, review of data points, findings from EDC and file reviews, etc.Perform monitoring visit report review and approval activities under the supervision of the project lead and line manager.Escalate to the project lead any issues and trends noted during the report review process.

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 documents filing, collections and validations.Coordinated work flow through assignment of tasks and establishment of procedures like Indexing of a regulatory document by using appropriate filing location in PSMT (Project Specific Tool Matrix). Assisted in the training of new team members on departmental procedures.Reviewed and QC of all documents which are processed Core, Country, site level clinical trial documents in eTMF.

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, I very & close out Visits as per ICH GCP • 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.• Overall site responsibilites taken care including the IP storage, Lab kit inventory, subject follow ups• Assited CRAs for all the required delegation and especially during audits as research manager• Managed all clinical trials conducted at site and monitored all the subjects data with EDC• Assisted to reconcile Investigational Product at site for multiple studies• Effectively monitored for Sponsored,QA and sponsored audits and successfully faced audits without any major findings.• Act as Project management coordinator for multiple projects at site level to ensure the process since Feasibility process to till the close out • Assist CRCs in data entry and query resolution process and ensured to have completeness• Assist with central lab supply coordination, Sample collection, storage, shipment and query resolutions if any• Ensured monitoring activity were performed and followed up in compliance with SOP.• Ensure to follow up with CRCs to keep the site and source files audit ready.• Was responsible for all administrative issues pertaining to the study related activities or facilities.

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 CRO QA.• 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.• Ensured monitoring activity were performed and followed up in compliance with SOP. • Coordinated to keep the site and source files audit ready. • Ensured update all study related logs including IP accountability, IP temperature logs, Screening logs etc.• Was responsible for all administrative issues pertaining to the study related activities or facilities. • Prepared and updated essential documents for new studies, which including regulatory documents, EC submissions and notificiations.• Registered subject visits in IVRS/IWRS and data entry in EDC.~ Worked for 35 Global and 2 National Clinical Trials.~ Studies on various Psychiatry Indications like Schizophrenia (Acute,Chronic), Bipolar Disorder, Dementia, Insomnia, Major Depressive Disorder(MDD), Epilepsy, Spinal Chord Injury, Hear failure, UC and others~ Faced FDA Inspection with appreciation and no findings.~ Faced Sponsor Audits.~ Worked on EDC tools like Inform4.5,4.6, Medidata RAVE, Oracle .~ Worked on Paper-CRF.

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. • Ensured update all study related logs including IP accountability, IP temperature logs, Screening logs etc.• Was responsible for all administrative issues pertaining to the study related activities or facilities. • Prepared and updated essential documents for new studies, which including regulatory documents, EC submissions and notificiations.

Master Of Business Administration - Mba, Operations Management And Supervision

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

Bsc, Andhra University