Sr. Local Trial Manager
hace 3 semanas
Sr. Local Trial Manager – Sponsor Dedicated. Local Trial Management services provide local management of a clinical trial(s) (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned project(s) at the country level for end‑to‑end project management from start‑up through to close‑out 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 5 years of local 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 strong 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 at #J-18808-Ljbffr
-
Senior Local Trial Manager for Sponsor-Dedicated Trials
hace 3 semanas
Buenos Aires, Argentina IQVIA A tiempo completoA global healthcare intelligence provider is looking for a Sr. Local Trial Manager in Buenos Aires, Argentina. In this role, you will oversee local trial management activities, ensuring compliance with regulations and managing project timelines. Candidates should possess a BA/BS and at least 5 years of local trial management experience in the pharmaceutical...
-
Local Trial Manager
hace 3 días
Buenos Aires, Argentina IQVIA A tiempo completo**Local Trial Manager - Sponsor Dedicated.** Primary point of contact to lead, mange and co-ordinate assigned project(s) at the country level for end-to-end project management from start-up through to closeout activities. **Tasks & Responsibilities**: - Partner with global, local country teams and study team to provide high level country strategy, drive...
-
Oncology Local Trial Manager – Solid Tumor
hace 1 semana
Buenos Aires, Argentina ICON A tiempo completoA global clinical research organization seeks a Local Trial Manager for Oncology trials in Buenos Aires. This role requires at least a BA/BS degree and 2 years of experience. The successful candidate will manage trial delivery, oversee local operations, and ensure compliance with regulations. Strong communication and IT skills are essential, along with a...
-
Local Trial Manager II
hace 5 días
Buenos Aires, Argentina Rockwell Automation A tiempo completoAt Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...
-
Remote Local Trial Manager
hace 1 semana
Buenos Aires, Argentina ICON A tiempo completoA leading clinical research organization seeks a Local Trial Manager in Buenos Aires to oversee clinical trials, collaborating with cross-functional teams and ensuring compliance with regulatory standards. The ideal candidate will hold a Bachelor's degree and possess at least a year of experience in clinical trial management, with skills in analytics and...
-
Local Trial Manager
hace 1 semana
Buenos Aires, Argentina ICON A tiempo completoLocal Trial Manager (FSP) - embedded within a leading, global pharma company 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. Role: Local Trial...
-
Clinical Trial Site Engagement Sr Manager
hace 3 días
Buenos Aires, Argentina Amgen A tiempo completoClinical Trial Site Engagement Sr Manager Develop, implement and maintain an integrated site engagement and operational role at key/targeted sites in line with Global Development pipeline to support strategic global study strategy plan to accelerate development of marketed products and early pipeline assets. Maintains an effective collaborative partnership...
-
Clinical Trial Site Engagement Sr Manager
hace 3 días
Buenos Aires, Argentina Amgen A tiempo completoCareer Category Clinical **Job Description**: Clinical Trial Site Engagement Sr Manager Develop, implement and maintain an integrated site engagement and operational role at key/targeted sites in line with Global Development pipeline to support strategic global study strategy plan to accelerate development of marketed products and early pipeline assets....
-
Remote Local Trial Manager
hace 3 semanas
Buenos Aires, Argentina Acento Recursos Humanos A tiempo completoA leading biotechnology company is seeking a Local Trial Manager to oversee clinical study implementation and drive study progress in Argentina. The ideal candidate should possess significant clinical trials experience and strong project management skills. Responsibilities include managing local study delivery and building relationships with sites. Remote...
-
Local Trial Manager
hace 4 días
Buenos Aires, Argentina ICON A tiempo completoLocal Trial Manager - Immunology - Home Based (US) 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. What you will be doing: The L-LTM role will be...