Summary
Overview
Work History
Education
Skills
Timeline
Computer and I.T Skills
Professional Development
Generic

Kelvin Ogega

Naivasha

Summary

Dedicated and detail-oriented professional with a strong background in data analysis and clinical research. Skilled in using statistical software such as R, SAS, and Stata, with experience in conducting and presenting public health research. Proven ability to manage clinical trials, coordinate operations, and draft thorough reports, ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements. Strong written and verbal communication skills, committed to advancing public health and improving health outcomes through evidence-based research. Seeking a challenging position in a fast-paced research setting to leverage skills and experience for a positive impact.

Overview

12
12
years of professional experience
1
1
Certification

Work History

Director, Quality Assurance

Spring Montagne Limited
07.2019 - Current
  • Attained 100% compliance with water quality and safety standards, strictly adhering to Kenya Bureau of Standards (KEBS) guidelines.
  • Ensured 100% personnel certification at the production plant and outlets for handling drinking water for human consumption.
  • Spearheaded a quality control team that enhanced product consistency, resulting in a 15% reduction in customer complaints.
  • Implemented a proactive system maintenance schedule, including regular servicing and membrane replacements, reducing machinery downtime by 20% and extending its lifespan by 25%.
  • Established and enforced rigorous sanitation schedules, conducting frequent internal audits to maintain high cleanliness standards.
  • Promoted a health and safety culture by prioritizing employee well-being and product quality, leading to a 30% improvement in workplace safety metrics.
  • Conducted regular testing of water samples to detect contaminants and ensure compliance with health standards, achieving a 99.5% pass rate.
  • Successfully procured safe and reliable packaging solutions for clean water distribution, increasing efficiency by 15%.

Clinical Research Associate

African Centre for Clinical Trials
11.2021 - 12.2022
  • Monitored the COVID-19 vaccine trial while adhering strictly to ICH-GCP regulations, ensuring the protection and well-being of human subjects, and maintaining an ethical study environment, resulting in zero compliance violations.
  • Oversaw informed consent procedures to maintain ethical conduct in the study, ensuring participants were well-informed and willing to participate, achieving a 100% informed consent rate.
  • Administered the study protocol and conducted comprehensive training for study-related procedures, enhancing protocol adherence and reducing procedural errors by 15%.
  • Communicated protocol and study concerns promptly, addressed deviations, and took corrective actions, improving overall study accuracy and reliability of collected data, resulting in a 20% improvement in data quality.
  • Performed comprehensive reviews of investigational product inventory, ensuring accurate tracking and secure study drug storage, resulting in zero compliance issues.
  • Executed thorough source data review and verification, meticulously documenting protocol deviations and handling data queries promptly, thus ensuring the accuracy, completeness, and reliability of collected data, with a 98% data accuracy rate.
  • Established clear communication channels with sites to manage project expectations and resolve issues, enhancing project efficiency and site satisfaction.
  • Proficiently utilized Electronic Data Capture systems and clinical trial management tools, resulting in a 25% reduction in data entry errors.
  • Developed and maintained strong relationships with trial site personnel and study coordinators, promptly addressing protocol and study concerns, which improved study retention and data quality.
  • Demonstrated exceptional organizational and time-management skills, consistently delivering assignments within tight timelines, reducing project delays by 20%.
  • Collaborated effectively, fostering improved cooperation among team members contributing to a 15% increase in overall project efficiency.
  • Reviewed and updated Investigator Site Files (ISF) and Trial Master Files (TMF) to ensure strict compliance with ICH guidelines, project SOPs, and sponsor requirements, achieving 100% completeness of essential study documents.
  • Provided regular and accurate site status updates, efficiently tracked study progress for sites, and ensured timely completion of study processes, improving overall study timelines.
  • Responded promptly and accurately to reported serious adverse events (SAEs), complying with regulatory requirements and prioritizing patient safety, maintaining a 100% compliance rate in SAE reporting.
  • Maintained precise site management documentation, including monitoring visit reports, follow-up letters, and action plans, ensuring high-quality and audit-ready records

Hospital Administrator

The Polyclinic Hospital
10.2012 - 12.2018
  • Increased efficiency by 60% by effectively managing pharmaceuticals, non-pharmaceuticals, laboratories, and other consumables, leading to streamlined operations and reduced waste.
  • Streamlined day-to-day operations and improved patient satisfaction by 45% by leveraging patient feedback and implementing necessary changes.
  • Provided exemplary customer service, resulting in a 95% patient satisfaction rate and fostering a positive experience for patients.
  • Built strong relationships with physicians to create a steady referral pipeline, increasing patient inflow by 25%.
  • Monitored patient flow to create an efficient check-in to check-out process, reducing patient wait times by 20%.
  • Coordinated patient care services across staff, physicians, patients, and practice departments, ensuring seamless communication and collaboration.
  • Ensured a positive patient experience through exceptional customer service, maintaining high patient interaction and care standards.
  • Collaborated with hospital staff to manage and enhance patient satisfaction, improving overall hospital rating.
  • Developed and executed standards and objectives to promote corporate vision, aligning departmental goals with organizational strategy.
  • Organized, directed, and coordinated medical and health services according to organizational policies and goals, enhancing overall departmental performance.
  • Engaged in regular communication with doctors, nurses, and employees to identify and resolve clients' healthcare needs, improving patient care outcomes.
  • Coordinated with patients and providers to schedule appointments, ensure on-time arrival, and follow up after appointments, achieving a 95% appointment adherence rate.

Education

Master of Public Health - Epidemiology and Disease Control

University of Eastern Africa, Baraton
Nandi, Kenya
08.2019

Bachelor of Science - Biomedical Technology

University of Nairobi
Nairobi, Kenya
08.2012

Skills

  • Statistical analysis and data interpretation
  • Study design and research methodologies
  • Knowledge of and experience with Stata and R
  • Interpersonal and Collaboration skills
  • Problem solving and Critical thinking skills
  • Written and Verbal communication skills
  • Attention to detail
  • Time management
  • Adaptability and flexibility

Timeline

Clinical Research Associate

African Centre for Clinical Trials
11.2021 - 12.2022

Director, Quality Assurance

Spring Montagne Limited
07.2019 - Current

Hospital Administrator

The Polyclinic Hospital
10.2012 - 12.2018

Master of Public Health - Epidemiology and Disease Control

University of Eastern Africa, Baraton

Bachelor of Science - Biomedical Technology

University of Nairobi

Computer and I.T Skills

  • Computer Proficient in Windows, Microsoft Office Package
  • CTMS - TOMS
  • Statistical Analysis Tools – SAS, R , and Stata
  • EDC - Clinflash, Oracle Clinical, Redcap, Medidata Rave
  • IVRS/IWRS - iRTON

Professional Development

  • Study Designs in Epidemiology, Imperial College London, May 2024
  • GCP for Clinical Trials with Investigational Drugs and Medical Devices, Society of Clinical Research Associates, Jan 2024.
  • Reproductive Health Issues, Global Health eLearning Centre, December 2021
  • Statistical Analysis with R for Public Health, Imperial College London, March 2021
  • The Challenges of Global Health, Duke University, June 2020
  • Monitoring and Evaluation, Global Health eLearning Centre, August 2019
  • Design and Interpretation of Clinical Trials, John Hopkins University, November 2019

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