Clinical Trial Manager jobs

Contribute to the design of the study protocols including sample size estimation and power analysis.Perform random number generation and patient allocation for RCT.Develop Statistical Analysis Plans (SAP), TLF shell and dataset specifications for SDTM and ADaM.Be an SDTM and ADAM expert providing advice and training.Writing analysis programs to meet specifications of the SAP/lead statistical prog...

Purpose of the positionThis position supports the Data Management and Biostatistics Team to ensure that all project data is analyzed and subjected to the required statistical tests based on the protocol and study designs and that final consistency checks on the data is done to assure its validity and completeness before any analysis can take place.Specific Job ResponsibilitiesContribute to the de...

Drugs for Neglected Diseases initiative (DNDi) is an independent, not-for-profit drug development initiative established in 2003 by five publicly-funded research organizations Malaysian Ministry of Health, Kenya Medical Research Institute, Indian Council of Medical Research, Oswaldo Cruz Foundation Brazil, and the Institut Pasteur as well as an international humanitarian organization, MÃ decins S...

Drugs for Neglected Diseases initiative (DNDi) is an independent, not-for-profit drug development initiative established in 2003 by five publicly-funded research organizations Malaysian Ministry of Health, Kenya Medical Research Institute, Indian Council of Medical Research, Oswaldo Cruz Foundation Brazil, and the Institut Pasteur as well as an international humanitarian organization, Médecins Sa...

Clinical Trial Manager at International AIDS Vaccine Initiative (IAVI)

Trial Manager, Kavi-Institute of Clinical Research at University of Nairobi

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...

JOB PURPOSE:To lead implementation of day to day activities as part of the Improving Hypertension Control in rural sub Saharan Africa (IHCor Africa) NIHR Global Health Research Group.Description:REPORTS TO:Reports tothe study PI.DIRECTLY SUPERVISES:Research Officer, Assistant Research Officer, Clinical officers, Fieldworkers, Post graduate diploma interns, Data manager, Data entry clerks.INDIRECT...

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...

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...

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...

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...