Patrick Mwanza Email & Phone Number

Kenya

As a Project Manager for cancer/oncology clinical trials site activation, I provide leadership, accountability & strategy for the regulatory, start-up, & maintenance activities. Plan, Manage, drive, and interpret as per clinical trial site activation process to accelerate innovation for healthier world. Differentiate with therapeutic expertise, science, and technology with deep committment to patients, sites, and customers.

Kenya

Oncology clinical trial operational oversight at global and regional level. Lead a variety of project management activities, including study design, start-up, execution, risk management, client engagement, mentorship, thought leadership, close-out, analysis, budget, and reporting, ensuring that the trial teams comply with ICH GCP, country-specific regulations and deliver high-quality data and trial documents. Willing to work on any project task as necessary to ensure collective success… Show more Oncology clinical trial operational oversight at global and regional level. Lead a variety of project management activities, including study design, start-up, execution, risk management, client engagement, mentorship, thought leadership, close-out, analysis, budget, and reporting, ensuring that the trial teams comply with ICH GCP, country-specific regulations and deliver high-quality data and trial documents. Willing to work on any project task as necessary to ensure collective success. Strongly believes that science has a role in the prevention, diagnosis and treatment of diseases, and the rehabilitation of patients. Show less

Kenya

Manage and lead clinical and public health project work streams/modules and client engagement. Implementation of projects and new business development. Client engagement roles.

Kenya

In this position, I was accountable for clinical and trial monitoring activities related to medical research conducted by the company. Was engaged in a variety of settings such as hospitals, medical research institutes, and government agencies depending on the jurisdiction, education, and certification requirements. To accomplish these tasks, I routinely conduct audits to determine the best and most efficient site which meets the requirements of the company to conduct the research program… Show more In this position, I was accountable for clinical and trial monitoring activities related to medical research conducted by the company. Was engaged in a variety of settings such as hospitals, medical research institutes, and government agencies depending on the jurisdiction, education, and certification requirements. To accomplish these tasks, I routinely conduct audits to determine the best and most efficient site which meets the requirements of the company to conduct the research program. These audits include monitoring the research sites during various phases of the study to ensure compliance with protocols and therapeutic areas. My actions have contributed to study trial oversight of numerous projects involving the RTSS Malaria vaccine, Malaria vaccine pharmacovigilance follow up study, HIV Ring study for microbicides, Ebola vaccine, and Epidemiological ACE study in sub Saharan Africa. One of my favorite tasks to complete is overseeing the training sessions to ensure all study personnel were updated, knowledgeable, and compliant with protocol requirements. These tasks are done by maintaining continual communications with each clinical site to address any issues and concerns as they occurred. This is done by using my expertise to generate recommendations for corrective actions which remained in compliance with clinical and regulatory guidelines. In addition to the above tasks, I also manage resources needed to meet timelines by generating reports and safety data based on the agreement and client requirements. I have also been held accountable for tracking regulatory submissions and approvals including patient recruitment and enrollment, processing the case report form (CRF) and query resolution. Show less

Kenya

Monitoring progress of clinical studies through on-site auditing of the centers to ensure clinical trials are conducted, recorded, and reported in accordance to the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.This was accomplished by performing on-site audits to process the selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. In addition, I was responsible… Show more Monitoring progress of clinical studies through on-site auditing of the centers to ensure clinical trials are conducted, recorded, and reported in accordance to the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.This was accomplished by performing on-site audits to process the selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. In addition, I was responsible for conducting training sessions with all relevant individuals assigned to the clinical trial and establish open lines of communication during the trials. I also evaluated the quality and integrity of the stakeholders at each site to ensure compliance with the requirements of the protocol and regulatory agencies. If there were any issues raised regarding the quality of the site, I escalated quality issues to the Clinical Team Lead (CTL) and /or line manager to handle as they saw fit. Show less

Kenya

To provide Clinical Operations expertise and strategic leadership in the evaluation, selection and management of clinical study sites and other external vendors to ensure successful clinical trial implementation and execution in several compounds, indications and therapeutic areas.To provide operational management, therapeutic knowledge and oversight for the successful management of international clinical trials (First in Human/Phase I - IV) across multiple indications through internal… Show more To provide Clinical Operations expertise and strategic leadership in the evaluation, selection and management of clinical study sites and other external vendors to ensure successful clinical trial implementation and execution in several compounds, indications and therapeutic areas.To provide operational management, therapeutic knowledge and oversight for the successful management of international clinical trials (First in Human/Phase I - IV) across multiple indications through internal clinical study teams and through the use of CROs and internal resources.To conduct project risk analysis and develops risk mitigation strategies for a variety of complex problems, in order to maintain study deliverables. Plays a role in ensuring that the Trial Team effectively interfaces with key functional groups. Show less

Nairobi

To oversee, manage and ensures clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs])To proactively manage clinical study site teams and investigators in all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelinesLead, plan, and execute clinical Investigator meetings, study meetings,… Show more To oversee, manage and ensures clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs])To proactively manage clinical study site teams and investigators in all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelinesLead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as neededLiaise with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationshipsDevelop and ensure execution of activities outlined in various study plans (data management, risk management, safety management, and study communication plans) Show less

Kenya

My main duties in this position revolved around the planning, implementation and reporting of the monitoring and evaluation strategy of the Maanisha Community Based HIV/AIDs initiatives project. Assisted in the development of project-based monitoring and evaluation (M&E) frameworks, track impact, and make recommendations.I was successful in this position because I thrived in the creating, developing, and managing of templates designed to track proposal development, donor reporting and other… Show more My main duties in this position revolved around the planning, implementation and reporting of the monitoring and evaluation strategy of the Maanisha Community Based HIV/AIDs initiatives project. Assisted in the development of project-based monitoring and evaluation (M&E) frameworks, track impact, and make recommendations.I was successful in this position because I thrived in the creating, developing, and managing of templates designed to track proposal development, donor reporting and other key endpoints of the research. I developed supervisory skills by overseeing junior researchers and providing background information regarding the tests conducted and mentor in the skills needed to conduct field monitoring duties. Show less

Kenya

Consistently meet and conduct regular meetings, trainings for healthcare professionals such as pharmacists, doctors, nurses, and other medical personnel who may provide patients with company products. Deployed engagement skills to promote the beneficial aspects of the company products.

Doctor Of Philosophy (Ph.D.), Epidemiology, In Progress

Activities and Societies: American Public Health Association - Member

Master Of Public Health - Mph, Epidemiology

Biochemistry, Medical Biochemistry