Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.Assess invest...
Discover Impactful Work:Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuri...
Discover Impactful Work: Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensur...
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to ma...
Regional Warehousing and distribution partners:Support selection of new partners by active assessment support during the due-diligence phase.Oversee closing of gaps and adherence to long-term Compliance Plans.Act as a first-level support for warehousing and distribution partners concerning quality-related topics including temperature excursions, complaints and issues which can also be handled dir...
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters. The Position A h...
The OpportunityRoche in Kenya has a vacancy for a Regional Quality Manager for the East Africa region who will ensure the maintenance and continual improvement of the Affiliate's quality system, in order to ensure compliance with the regulations and Roche requirements. You as our successful candidate will support in overseeing warehousing and distribution partners within the East Africa region re...
Job Overview:Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.Prepare site regulatory documents, reviewin...
Provide administrative support to clinical projects under direction of line manager and/or other designated clinical team members. Assists with general administrative functions as required.Responsibilities Assist Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track sit...
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare a strategy that aims to fit the right treatment to each patient in the best way possible The Opportunity1 Roche in Kenya has a vacancy for a Regional Quali...
IQVIA, formerly Quintiles and IMS Health, Inc.,is an American multinational company serving the combined industries of health information technology and clinical research About the job Provide administrative support to clinical projects under direction of line manager and/or other designated clinical team members. Assists with general administrative functions as required. Responsibilities Assist ...
Job Description Job Overview: Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. Prepare site regulatory ...
Summary of the Position:The Clinical Project Manager (PM) serves an important role within the company and is a person who leads the delivery of our studies. The PM serves as the primary liaison between FHI Clinical's study teams and the customer and serves as that accountable point for delivery and quality of projects, whilst maintaining financial control. As a project leader you will manage cros...
PURPOSEUsing broad management discretion, direct, oversee and manage complex, regulatory project(s), ensuring quality deliverables on time and within budget. Ensure that all work is completed in accordance with SOPs, policies and practices.RESPONSIBILITIESBuilding relationships with African regulators and ECsEngage with regional stakeholders (e.g. African union, Africa Medicine agency, etc.) to d...
IQVIA, formerly Quintiles and IMS Health, Inc.,is an American multinational company serving the combined industries of health information technology and clinical research PURPOSE Using broad management discretion, direct, oversee and manage complex, regulatory project(s), ensuring quality deliverables on time and within budget. Ensure that all work is completed in accordance with SOPs, policies a...
IQVIA is strategically positioned for growth in Africa and are working on innovative collaborations with customers, industry bodies and key players in the broader R&D and Global Public Health arena. This role would bring a strong regional focus and collaboration with the scientific community to enhance the clinical trials delivery ecosystem.PURPOSE Using broad management discretion, direct, overs...
Purpose of consultancyThe purpose of the Roster of Experts (ROE) is to provide trusted technical, scientific, regulatory, leadership, and management support to the AVAREF Secretariat, which will, in turn, support the development of comprehensive regulations for clinical trials, procedures for review of Clinical Trials Applications and dossiers for registration of vaccines, bio-therapeutics, pharm...
The World Health Organization is a specialized agency of the United Nations that is concerned with international public health. It was established on 7 April 1948, headquartered in Geneva, Switzerland. Purpose of consultancy The purpose of the Roster of Experts (ROE) is to provide trusted technical, scientific, regulatory, leadership, and management support to the AVAREF Secretariat, which will, ...
IAVI is seeking a highly motivated Senior Clinical Trial Manager (CTM) who manages, oversees and executes day-to-day operational activities for the conduct of clinical trials according to ICH/GCP guidelines and relevant regulatory guidelines. The Sr. CTM will lead clinical operations of early and late phase and/or highly complex clinical trials, mentor other clinical operations staff, and lead pr...
Regulatory and Start Up Specialist IQVIA RSUWork from any location Must speak Dutch and EnglishJoin us on our exciting journey!IQVIA Clinical Functional Services Partnerships (FSP) business is unique. Our teams are dedicated to a single sponsor partner, where the common goal is quality delivery for our customers. We set ourselves apart with collaboration and face to face contact both at start up ...
Job Description A day in the Life: Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote...
A day in the Life:Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activi...
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to ma...
Job Summary:The officer will be responsible for overseeing all stages of the development and implementation of research in western Kenya, including sustained stakeholder engagement with national and sub-national MOH partners, conduct formative and pilot research phases, and trial implementation. S/he will chair in-country management meetings and be responsible for the preparation of standard oper...
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