Local Trial Manager
Há 1 mês
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 closeout activities.
Tasks & Responsibilities:
- Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), and 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 1 year 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-
Local Trial Manager
6 meses atrás
Sao Paulo, Brasil Amgen Tempo inteiro**HOW MIGHT YOU DEFY IMAGINATION?** You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology...
-
Local Trial Manager
2 semanas atrás
São Paulo, SP, Brasil Amgen Tempo inteiro**HOW MIGHT YOU DEFY IMAGINATION?** You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...
-
Local Trial Manager
3 meses atrás
São Paulo, SP, Brasil Amgen Tempo inteiro**Job Description**: **HOW MIGHT YOU DEFY IMAGINATION?** You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one...
-
Local Trial Manager
1 semana atrás
São Paulo, Brasil Amgen Tempo inteiroYou’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies,...
-
Clinical Trials Manager
4 semanas atrás
São Paulo, São Paulo, Brasil Amgen Tempo inteiro{"**Job Title:** **Local Trial Manager** **Job Summary:** We are seeking a highly skilled and experienced Local Trial Manager to lead and manage the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and other applicable local regulations. **Key Responsibilities:** * Partner with global and local...
-
Clinical Trials Manager
3 semanas atrás
São Paulo, São Paulo, Brasil Amgen Tempo inteiro**Clinical Trials Manager Role**At Amgen, we're committed to serving patients through innovative treatments. As a Clinical Trials Manager, you'll play a vital role in leading and coordinating clinical trials from start to finish.**Key Responsibilities:**- Partner with global and local teams to drive study progress and delivery- Plan, manage, and oversee...
-
Clinical Trial Manager
4 semanas atrás
São Paulo, São Paulo, Brasil Icon Plc Tempo inteiroJob Title: Clinical Trial ManagerAt ICON plc, we are seeking a highly skilled Clinical Trial Manager to join our Real World Solutions team. As a Clinical Trial Manager, you will be responsible for the operational oversight of all milestones and activities assigned to projects, including site management and monitoring activities.Key Responsibilities:Develop...
-
Clinical Trial Manager
3 semanas atrás
São Paulo, São Paulo, Brasil Medpace, Inc. Tempo inteiroMedpace, Inc. is seeking a full-time Regulatory Submissions Manager to join our Study Start Up team in Sao Paulo. This position plays a key role in the clinical trial management process.Key Responsibilities:Efficiently manage and successfully execute clinical trial submissions.Collaborate with cross-functional teams to ensure timely and accurate...
-
Clinical Trial Manager
4 semanas atrás
São Paulo, São Paulo, Brasil Allucent Tempo inteiroJob Title: Senior Clinical Trial LeaderWe are seeking a highly experienced Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and oversight to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial...
-
Clinical Trials Manager
3 semanas atrás
São Paulo, São Paulo, Brasil Allucent Tempo inteiroJob SummaryWe are seeking a highly skilled and experienced Clinical Trials Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other functional groups in their day-to-day clinical trial activities.Key...
-
Clinical Trials Manager
4 semanas atrás
São Paulo, São Paulo, Brasil Allucent Tempo inteiroSenior Clinical Trial LeaderWe are seeking a highly experienced and skilled Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and oversight to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical...
-
Clinical Trial Manager
3 semanas atrás
São Paulo, São Paulo, Brasil Medpace, Inc. Tempo inteiroMedpace, Inc. is seeking a full-time Regulatory Submissions Manager to join our Study Start Up team in Sao Paulo. This position plays a key role in the clinical trial management process. Key responsibilities include efficiently managing and successfully submitting regulatory documents.Key Responsibilities:Manage and submit regulatory documentsCollaborate...
-
Clinical Trials Manager
2 semanas atrás
São Paulo, São Paulo, Brasil Medpace, Inc. Tempo inteiroKey Responsibilities:As a Regulatory Submissions Manager at Medpace, you will play a vital role in the clinical trial management process. Your primary focus will be on efficiently managing and successfully completing regulatory submissions for our LATAM clinical trials.Key Skills and Qualifications:• Strong expertise in clinical trial management and...
-
Clinical Trial Manager
2 semanas atrás
São Paulo, Brasil ICON plc Tempo inteiroClinical Trial Manager - Argentina, Buenos Aires 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. We are currently seeking a Clinical Trial...
-
Clinical Trial Operations Manager
3 semanas atrás
São Paulo, São Paulo, Brasil Allucent Tempo inteiroJob SummaryWe are seeking a highly skilled Clinical Trial Operations Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other clinical functional groups. Your primary focus will be on ensuring the successful...
-
Clinical Trial Manager
Há 1 mês
São Paulo, São Paulo, Brasil Bancroft School Tempo inteiroJob Title: Clinical Trial ManagerMedpace is a leading Contract Research Organization (CRO) that provides clinical development services to the biotechnology, pharmaceutical, and medical device industries. We are seeking an experienced Clinical Trial Manager to join our team in Sao Paulo, Brazil.Responsibilities:Manage and provide accountability for day-to-day...
-
Clinical Trial Operations Manager
1 semana atrás
São Paulo, São Paulo, Brasil Bancroft School Tempo inteiroLead Clinical Trial OperationsLogin to a dynamic and growing team of professionals at Medpace, a leading Contract Research Organization (CRO) providing clinical development services to the biotechnology, pharmaceutical, and medical device industries.We are seeking a highly skilled Clinical Trial Operations Manager to join our Sao Paulo, Brazil team. As a key...
-
(Senior) Clinical Trial Manager
5 meses atrás
São Paulo, Brasil IQVIA Tempo inteiroClinical Trial Manager – Sponsor Dedicated. Clinical Trial Manager provides for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agree upon...
-
Clinical Trial Operations Manager
3 semanas atrás
São Paulo, São Paulo, Brasil Allucent Tempo inteiroSenior Clinical Trial Leader Job DescriptionAbout the Role:We are seeking a highly skilled and experienced Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other clinical functional...
-
Senior Clinical Trial Manager
1 semana atrás
São Paulo, Brasil Icon plc Tempo inteiroSenior Clinical Trial Manager, Internal Medicine / LATAM / RemoteICON 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. We are currently seeking a Senior...
