Amresh Kumar Email & Phone Number

Delhi, Dl, In

New Delhi, Delhi, India

Program Implementation:Responsible for the implementation of Kala-azar, Lymphatic Filariasis, Malaria and Dengue work at PATH.Provide technical support to Government of India and Government of Uttar Pradesh to achieve Kala-Azar elimination and sustain the elimination and Lymphatic Filariasis. Provide inputs in development and finalization of Guidelines, SOPs and reporting formats related to the NTD program specially VL and LF.Also leading the PATHs work in malaria (vivex) radical… Show more Program Implementation:Responsible for the implementation of Kala-azar, Lymphatic Filariasis, Malaria and Dengue work at PATH.Provide technical support to Government of India and Government of Uttar Pradesh to achieve Kala-Azar elimination and sustain the elimination and Lymphatic Filariasis. Provide inputs in development and finalization of Guidelines, SOPs and reporting formats related to the NTD program specially VL and LF.Also leading the PATHs work in malaria (vivex) radical cure and Dengue control activities. Advocacy with Government of Bangladesh and Nepal on Kala-Azar elimination strategies.Close coordination with the Central Government, stake holder and partner management in India, Bangladesh, Nepal and Sri LankaProvides input in finalizing various guidelines at national level.Proposal review and budget negotiation with sub-grantee.Clinical Studies:Manage clinical studies set- up and their monitoring as per the ICH-GCP and other applicable regulatory guidelines.Provide clinical expertise, strategic planning and support clinical activities.Review protocol and study documents of clinical studies to ensure that the study documents are complete and aligned with the I applicable regulatory requirements.Negotiate clinical trial agreement and budget with the investigators and site.Identify key opinion leader (KOL) and subject matter experts.Ensure study participants are on track and all applicable regulatory requirements are fulfilled.Review study reports and line list.Provide medical oversights and inputs to the studiesPharmacovigilance: Training of National regulatory agency and National Kala-Azar elimination program (Nepal and Bangladesh) to improve their pharmacovigilance system. Provided supervision and technical support to these activities.Training: Supported the training of ethics committee members and researchers to improve their work and review system.PKDL Consortium: Leading PKDL consortium convening. Show less

New Delhi Area, India

Specific job responsibility includes:• Development, implementation and monitoring of clinical trials and studies and ensure that Good Clinical Practices is followed.• Involved in managing large scale clinical trial projects, monitoring investigator sites, reviewing protocols, participating in proposal meetings and preparing and reviewing reports• Interact closely with the investigator site to manage the trial logistics, ensuring compliance with protocol and completion of trial… Show more Specific job responsibility includes:• Development, implementation and monitoring of clinical trials and studies and ensure that Good Clinical Practices is followed.• Involved in managing large scale clinical trial projects, monitoring investigator sites, reviewing protocols, participating in proposal meetings and preparing and reviewing reports• Interact closely with the investigator site to manage the trial logistics, ensuring compliance with protocol and completion of trial according to study timelines.• Development of Standard Operating Procedures Writing of New Drug Applications protocols, case report forms, informed consent forms, Standard Operating Procedures, medical reports, efficacy and safety summaries for clinical trials to international standards.• Preparation of Grant submissions, budgets and contracts.• Conducts site visits for medical/ICH-GCP oversight including pre-study, at study initiation, at regular intervals during the study and at study closeout.• Monitors investigator performance and adherence to protocol and proactively addresses conduct issues and enrolment problems, as necessary.• Ensures that reported trial data are accurate, complete, and verifiable.• Interact with data management to plan data entry and analysis.• Ensure timely completion of trials.• Ensure that all clinical research activities are in compliance with current local and international regulations, laws, guidance Show less

Delhi

Will be responsible for leading for one or more clinical trials simultaneously and be responsible for the initiation, conduct and reporting of clinical trials or programs working in partnership with the CRO Project Manager. They will ensure by co-ordination of project team activities that these projects are completed on or ahead of time and on target, according to the requirements of the contract with the Sponsor and ensure that project activities are executed according to the quality standards… Show more Will be responsible for leading for one or more clinical trials simultaneously and be responsible for the initiation, conduct and reporting of clinical trials or programs working in partnership with the CRO Project Manager. They will ensure by co-ordination of project team activities that these projects are completed on or ahead of time and on target, according to the requirements of the contract with the Sponsor and ensure that project activities are executed according to the quality standards defined by appropriate procedures and by ICH GCP.Medical Monitoring and Pharmacovigilance:• Strengthening of the current Pharmacovigilance System in Bangladesh and Nepal• Provide training to the Health Care Provider (HCP)• Finalize ADR reporting form and manuals• Organize and participate in steering committee meeting • Review of SAE form reported by the site and CRO• Provide input on the reported SAE form and their narrativesDonors and Stake Holders Managements:• Liasion with the investigators and the MoH officials for the meeting and planning.• Liasion with the experts and other stake holders.• Liasion with Drug Manufacturer for production and registration related activities.• Liasion with consortium partners.• Donor report preparation and finalization.• Provide inputs in the new proposals preparations including budget as and when required. Show less

Delhi

Specific job responsibility includes:• Development, implementation and monitoring of clinical trials and studies and ensure that Good Clinical Practices is followed.• Involved in managing large scale clinical trial projects, monitoring investigator sites, reviewing protocols, participating in proposal meetings and preparing and reviewing reports• Interact closely with the investigator site to manage the trial logistics, ensuring compliance with protocol and completion of trial… Show more Specific job responsibility includes:• Development, implementation and monitoring of clinical trials and studies and ensure that Good Clinical Practices is followed.• Involved in managing large scale clinical trial projects, monitoring investigator sites, reviewing protocols, participating in proposal meetings and preparing and reviewing reports• Interact closely with the investigator site to manage the trial logistics, ensuring compliance with protocol and completion of trial according to study timelines.• Development of Standard Operating Procedures Writing of New Drug Applications protocols, case report forms, informed consent forms, Standard Operating Procedures, medical reports, efficacy and safety summaries for clinical trials to international standards.• Preparation of Grant submissions, budgets and contracts.• Conducts site visits for medical/ICH-GCP oversight including pre-study, at study initiation, at regular intervals during the study and at study closeout.• Monitors investigator performance and adherence to protocol and proactively addresses conduct issues and enrolment problems, as necessary.• Ensures that reported trial data are accurate, complete, and verifiable.• Interact with data management to plan data entry and analysis.• Ensure timely completion of trials.• Ensure that all clinical research activities are in compliance with current local and international regulations, laws, guidance Show less

Responsible for operational performance of clinical programs to ensure that program milestones and objectives are met. Responsible for line management of clinical operations personnel (Study Managers) and matrix management of their direct reports ( CRCs, and Clinical Trial Administrators). Responsbile for infrastructure development including SOPs, process maps, working practice documents, departmental training and career development to support management and monitoring of clinical programs… Show more Responsible for operational performance of clinical programs to ensure that program milestones and objectives are met. Responsible for line management of clinical operations personnel (Study Managers) and matrix management of their direct reports ( CRCs, and Clinical Trial Administrators). Responsbile for infrastructure development including SOPs, process maps, working practice documents, departmental training and career development to support management and monitoring of clinical programs. Provide direction and advise clinical staff regarding programs designed to support company effort to obtain regulatory approval in various therapeutic areas.Currently 168 Clinical Research Staff is reporting to me. Show less

Primarily responsible for line management of clinical operations personnel as well as development of infrastructure supporting NDA studies including SOP development, departmental training and career development. Guide and advise clinical operations personnel regarding programs designed to support NDA company objectives in various therapeutic areas. Responsible for financial and operational performance of clinical programs to ensure program milestones and objectives are met.Directed and… Show more Primarily responsible for line management of clinical operations personnel as well as development of infrastructure supporting NDA studies including SOP development, departmental training and career development. Guide and advise clinical operations personnel regarding programs designed to support NDA company objectives in various therapeutic areas. Responsible for financial and operational performance of clinical programs to ensure program milestones and objectives are met.Directed and coordinated clinical research programs designed to support company's effort to obtain approval of NDA or ANDA products in various therapeutic areas. Responsibilities included set-up, planning and delivery of assigned projects in accordance with scope of work as defined by project protocol, budget, timelines and company objectives. Tracking and overseeing project progress including day-to-day activities of internal team and vendors to meet project quality, budget and timeline specifications. Ensuring clear communication between project team, vendors and sponsor management. Preparation of weekly project status reports, facilitation of weekly project team meetings, resource planning, participation in development of protocols, CRFs, ICFs and other clinical trial documents. Development of RFPs for vendors, analysis of proposals and recommendations to management. Overall responsibility for the management of the entire project including the relationship management with both Sponsors and Investigators. Show less

New Delhi, Delhi, India

Clinical Research Physician in Rota Virus Vaccine Development Project. The product is registered in country and part of vaccination program of Government of India.