Clinical trial manager
3 semanas atrás
Clinical Trial Manager – Sponsor Dedicated. Clinical Project Management services provide management of a clinical trial (s) in a regional level. Services/deliverables include operational oversight of assigned project(s) at the regional level for end-to-end project management from start-up through to closeout activities. Tasks & Responsibilities: Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements. Prepares or contributes to high level budget estimate in response to Request for Service's followed by detailed budget proposal. Ensures overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract. Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting. Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits. Escalates corrective and preventive actions (CAPA) to GTL MAO and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target. Contributes to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations. Essentials Requirements: BA/BS degree. Degree in a health or science related field. Minimum of 2 years of local/regional trial management experience in the pharmaceutical industry or CRO and previous experience as Clinical Research Associate. Specific therapeutic area experience may be required depending on the position. Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures. Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs. Excellent decision-making and string financial management skills. Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more
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Clinical Project Manager **Level Dependent on Experience**
2 semanas atrás
São Paulo, Brasil CTI Clinical Trial and Consulting Services Tempo inteiroClinical Project Manager (Level Dependent on Experience) Join to apply for the Clinical Project Manager (Level Dependent on Experience) role at CTI Clinical Trial and Consulting Services. CTI Clinical Trial and Consulting Services is a global, privately held, full‑service clinical contract research organization (CRO) focused on the advancement of...
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São Paulo, Brasil CTI Clinical Trial and Consulting Services Tempo inteiroClinical Project Manager Level Dependent on Experience Join to apply for the Clinical Project Manager Level Dependent on Experience role at CTI Clinical Trial and Consulting Services Get AI-powered advice on this job and more exclusive features. CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research...
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Clinical Trial Manager
1 semana atrás
São Paulo, São Paulo, Brasil ICON plc Tempo inteiro R$90.000 - R$120.000 por anoClinical Trial Manager (FSP - Sponsor Dedicated)ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Clinical Trial Manager to...
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Clinical Trial Manager
2 semanas atrás
São Paulo, São Paulo, Brasil IQVIA Tempo inteiro R$60.000 - R$120.000 por anoClinical Trial Manager – Sponsor Dedicated.Clinical Project Management services provide management of a clinical trial (s) in a regional level. Services/deliverables include operational oversight of assigned project(s) at the regional level for end-to-end project management from start-up through to closeout activities.Tasks & Responsibilities:Services...
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Clinical Trial Manager
Há 7 dias
São Paulo, Brasil ICON Tempo inteiroClinical Trial Manager in IPH ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
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Clinical Trial Coordinator
Há 19 horas
São Paulo, Brasil Merck Gruppe - MSD Sharp & Dohme Tempo inteiroJob Description Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable. The...
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Clinical Trial Oversight Manager
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São Paulo, Brasil Amgen Tempo inteiro**Join Amgen’s Mission of Serving Patients** At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on...
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Clinical Trial Coordinator
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São Paulo, Brasil Merck Tempo inteiroJob Description Under the oversight of the line‑manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non‑clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable....
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Clinical Trial Manager
Há 7 dias
São Paulo, Brasil ICON Tempo inteiroClinical Trial Manager II you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions. What will you be doing? Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up (COLA) to close out at a country level in...
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Clinical Trial Coordinator
Há 19 horas
São Paulo, Brasil MSD Malaysia Tempo inteiroJob DescriptionUnder the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.The...
