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...
Kenya Medical Research Institute (KEMRI) is a State Corporation established through the Science and Technology (Amendment) Act of 1979, which has since been amended to Science, Technology and Innovation Act 2013. The 1979 Act established KEMRI as a National body responsible for carrying out health research in Kenya. Job Summary: The officer will be responsible for overseeing all stages of the dev...
The International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS. Summary 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 an...
Kenya Medical Research Institute (KEMRI) is a State Corporation established through the Science and Technology (Amendment) Act of 1979, which has since been amended to Science, Technology and Innovation Act 2013. The 1979 Act established KEMRI as a National body responsible for carrying out health research in Kenya. Responsibilities The duties and responsibilities of the officer will entail: Recr...
The International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS. Position Summary: Are you passionate about Clinical Research and eager to make a difference in a mission-driven organization? IAVI is seeking an experienced Director, Community Engagement who will implement Good Parti...
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...
Key Responsibilities: Act as clinical operations lead on project teams for assigned studies. Develop the protocol management plan (PMP) and coordinate the development of operations plans for all applicable functions for inclusion in the PMP. Develop study timelines and ensure adherence; Escalates concerns / issues related to timelines to senior management appropriately. Lead team meetings and con...
Job Overview Manage a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and meeting project objectives. Essential Functions Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work, assessing performance and guiding profes...
POSITION SUMMARY: IAVI is seeking experienced, dynamic and ambitious Community Engagement professionals to help advance the mission of making a positive impact in global health! The Specialist or Manager, Community Engagement will coordinate, monitor, and implement Community Engagement Programs. The Community Engagement expert will facilitate and implement Good Participatory Practice (GPP) at cli...
About the job 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 activitie...
IQVIA, formerly Quintiles and IMS Health, Inc.,is an American multinational company serving the combined industries of health information technology and clinical research. It is a provider of biopharmaceutical development and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services, including consulting services. It has a n...
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, revie...