George Ochenge

Experience

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  International Centre for Reproductive Health (ICRH)

  Apr 2004 - Aug 2005

  • Maintaining internal Quality Control in a WHO-run multinational, multicentre clinical trial on impact of HAART on MTCT, pregnancy and breastfeeding in Mombasa, Kenya.• Study Clinic Procedures: Monitoring that they are done according to GCP, Study Protocol and SOPs.• Case Report Forms/ Data management: Monitoring that all these are done according to ICH/GCP Guidelines.• Laboratory: Ensuring SOPs are adhered to and GCP reporting systems are followed.• Procurement of WHO-Prequalified ARVs.• Maintenance of Essential Documents Files and other Study Documents.• Liaison with External Study Monitor in site monitoring visits.• Conducting site monitoring checks of study laboratory and study clinic for compliance with GCP.• Assisting the Principal investigator (PI) in liaisons with the IRB, DSMB and other partners. Show less • Maintaining internal Quality Control in a WHO-run multinational, multicentre clinical trial on impact of HAART on MTCT, pregnancy and breastfeeding in Mombasa, Kenya.• Study Clinic Procedures: Monitoring that they are done according to GCP, Study Protocol and SOPs.• Case Report Forms/ Data management: Monitoring that all these are done according to ICH/GCP Guidelines.• Laboratory: Ensuring SOPs are adhered to and GCP reporting systems are followed.• Procurement of WHO-Prequalified antiretrovirals (ARVs).• Maintenance of Essential Documents Files and other Study Documents.• Liaison with External Study Monitor in site monitoring visits.• Conducting site monitoring checks of study laboratory and study clinic for compliance with GCP.• Assisting the Principal investigator (PI) in liaisons with the IRB, DSMB and other partners. Show less

  • Clinical Research Associate/Quality Assurance Monitor

    Apr 2004 - Aug 2005

  • Clinical Research Associate/Quality Assurance Monitor

    Apr 2004 - Aug 2005
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  Kenyatta National Hospital, Nairobi, Kenya

  Sept 2005 - Sept 2006

  Monitoring and Evaluation Officer, HIV Projects

  • Monitoring and Evaluation of HIV Projects at the VCT and Comprehensive Care Centre for HIV.• Analyzing data generated by the Centres by exit interviews and other data collection systems.• Development of SOPs for these Centres as part of the hospital’s effort to acquire ISO 9001 Certification, and ensuring they are adhered to.• Preparation of quarterly reports for the hospital and the funding agencies.• Development of data collection tools for use at these Centres.• Teaching in training programmes offered by VCT Centre (VCT, DTC, Couple VCT, Adherence counselling etc)• Participation in the National Quality Assessment & Assurance in VCT (NQAT), run by NASCOP.• Development of databases for entry of data generated from these areas.• Assisting in monitoring of provision of quality services within the Centres and in mentored sites within Nairobi. Show less

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  Family Health International

  Jun 2006 - Jul 2009

  Clinical Research Associate

  • Managing Clinical Trials in the Africa Region• Monitoring of Clinical Trials to ensure compliance with GCP, ICH guidelines, the Protocol, FDA, FHI policies and SOPs, applicable local requirements and other standards as appropriate.• Link between the Site and the Sponsor.• Train site staff on specific protocol requirements and other applicable requirements.• Retrieving of monitored CRFs for onward transmission to data management.• Reporting of and follow up of SAEs, pregnancies to final resolution.• Query resolution and follow up any missing data.• Manage the completeness of the regulatory binder at site and the Central one.• Supervise and provide technical assistance to other Clinical Research Associates (CRAs).• Preparation of data monitoring plans, monitoring reports, final reports and/or publications.• Identify new sites and conduct assessment of sites for suitability for FHI studies, and participate in all stages of studies from site development, initiation, interim and close-out monitoring stages of the trial(s).• Training site staff and mentoring them in ICH-GCP compliance.• Coordinating the shipment of study supplies, drugs, laboratory equipment and reagents to all the 7 sites in Africa.• Preparation of study administration and analysis tools, SOPs and manuals. Show less

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  Population Council

  Nov 2010 - Dec 2010

  Management Information System Analyst

  Management of data from participating health facilities to inform decision making

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  Quintiles

  Jan 2011 - Apr 2016

  Senior Clinical Research Associate

  • Managing Clinical trials in the African Region.• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and Good Clinical Practice, across the full life-cycle of clinical research.• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.• Mentoring new CRAs during on-boarding to support them to learn Quintiles processes and systems. Show less

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  Janssen Pharmaceutica (a company of Johnson and Johnson)

  May 2016 - Sept 2020

  Site Manager

  Managing clinical research sites in East Africa

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  Clintec

  Sept 2020 - Sept 2021

  Clinical Operations Manager
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  PPD

  Sept 2021 - now

  Project Lead/Project Manager — Vaccines