Clinical Trials Associate Manager
hace 4 semanas
As a leading global contract research organization (CRO), SAO Fortrea Brazil Limitada provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, our company is transforming drug and device development for partners and patients across the globe.
Job Summary
The Central Monitoring Associate Manager is responsible for the execution of key Central monitoring (site, subject & study level review as applicable) activities. This role collaborates within a matrix environment, communicates proactively internally and externally, and across functions with key stakeholders to ensure Central Monitoring is proactively and effectively executed to meet client expectations.
Main Responsibilities
- Perform Central monitoring activities for multiple studies for customers and ensure accurate tracking and status reporting of studies in their remit.
- Act as the Lead for the Central Monitoring team for more than one study for multiple customers.
- Support Manager and leadership in preparation of detailed study risk assessment and in Sponsor presentations / bid defenses.
- Ensure that tracking and status reporting are performed in a timely and accurate manner.
- Contribute to the Risk Assessment and Categorization Tool (RACT) for topics related to central Monitoring and/or medical reviews and considers risks when planning tools configuration.
- Support the Data Expert with Critical Data and Process Definition and EDC design implementation.
- Support the development of informatics Platform requirements, including design of the visualizations, taking into consideration the data feeds for the study (EDC, laboratory, etc.).
- Collate requirements including prescriptive risk factor mitigation strategies, SDV strategy, study-specific risk factor definition, variable risk factor trigger levels.
- Draft the Configuration Plan and all other applicable Plans in collaboration with the study team and update these on an ongoing basis, including the refinement of visualizations and any edits in line with emerging risk profile and study changes.
- Edit the Central Monitoring and other applicable plans in line with emerging risk profile and study changes.
- Populate the tools, test variable risk factors, adjust trigger levels, study-specific risk factors, and central monitoring parameters.
- Perform ongoing reviews, prepare and recommend mitigation actions, and reviews recommended monitoring levels with project team and ensure that identified issues are followed to resolution.
- Propose potential changes to monitoring intervention level on behalf of the project team in line with overall strategies.
- Prepare and distribute the Project/Study Reports at intervals during study conduct and at study close out.
Requirements
- University/college degree or post-graduation (life science preferred) from an appropriately accredited institution.
- Minimum of 6-8 years of relevant clinical research experience in a pharmaceutical company/CRO or other equivalent experience with increasing levels of responsibility in clinical trial-related roles e.g. project management, clinical monitoring, data management, and informatics.
- Fluent English.
- End-to-End RBQM experience is preferred.
-
Operations Associate
hace 4 semanas
Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completoAbout the RoleThe Operations Associate has primary responsibility for carrying out all daily aspects of the operational work related to rater selection, rater certification/qualification, rater training content, scale acquisition, surveillance maintenance, and workbook/source document for Worldwide Clinical Trials, Inc. (WCT).The Operations Associate works...
-
Clinical Trials Operations Coordinator
hace 4 días
Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completoCompany Overview:Worldwide Clinical Trials (WCT) is a leading global contract research organization that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications.The company has a dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, which...
-
Clinical Research Manager
hace 4 semanas
Ciudad de México, Ciudad de México MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completoJob SummaryMEX Labcorp Clinical Development, S. de R.L. de C.V. is seeking a highly skilled Clinical Research Manager to lead our global clinical trials efforts. As a key member of our team, you will be responsible for managing clinical trials from feasibility to close-out, ensuring compliance with regulatory requirements and company standards.Key...
-
Clinical Research Specialist
hace 4 semanas
Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completoAbout the RoleWe are seeking a skilled Clinical Research Specialist to join our team at Worldwide Clinical Trials. As a Clinical Research Specialist, you will be responsible for all aspects of assigned projects, including clinical assessment, training development, and data review.Key ResponsibilitiesAssist in the review of eCOA/ePRO specifications and engage...
-
Ciudad de México, Ciudad de México Covance Latinoamérica A tiempo completoJob OverviewWe are seeking a highly motivated and organized Clinical Research Associate to join our team in Covance Latinoamérica. As a Clinical Research Associate, you will be responsible for managing clinical trials from start to finish, ensuring compliance with regulatory requirements and maintaining high-quality data.About the JobEstimated Salary:...
-
Clinical Trials Project Manager
hace 7 días
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob OverviewWe are seeking an experienced Clinical Trials Project Manager to lead and oversee the execution of clinical projects and research studies in accordance with global and local regulations.Key Responsibilities:Support in ensuring compliance with contract, SOPs, GCPs, policies, and regulatory requirements.Meeting quality & timeline metrics.Effective...
-
Clinical Assessment Specialist
hace 4 días
Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completoWorldwide Clinical Trials (Worldwide) is a leading global contract research organization that works in partnership with biotechnology and pharmaceutical companies to create customized solutions for advancing new medications.We are seeking a highly skilled Clinical Assessment Specialist to join our team. As a key member of the Clinical Assessment Technologies...
-
Clinical Trials Specialist
hace 4 semanas
Ecatepec de Morelos, México Syneos Health Clinical A tiempo completoAbout the RoleSyneos Health Clinical is seeking a highly skilled Clinical Trials Specialist to join our team. As a Clinical Trials Specialist, you will be responsible for ensuring the smooth conduct of clinical trials, from site qualification to close-out visits. You will work closely with project teams to ensure regulatory compliance and provide guidance to...
-
Clinical Trials Risk Manager
hace 1 semana
Ciudad de México, Ciudad de México SAO Fortrea Brazil Limitada A tiempo completoSAO Fortrea Brazil Limitada is seeking a highly skilled Clinical Trials Risk Manager to join their team.About the RoleThis is a critical position that requires a deep understanding of clinical trials and risk management. As a Clinical Trials Risk Manager, you will be responsible for ensuring the full implementation of the risk plan and recommending...
-
Global Clinical Trials Manager
hace 1 día
Ciudad de México, Ciudad de México Eli Lilly and Company A tiempo completoJob OverviewWe are seeking a highly skilled Global Clinical Trials Manager to join our team at Eli Lilly and Company.About the RoleThe successful candidate will lead and manage a team of clinical research professionals within the country, collaborating with business partners to ensure clinical trials/studies across all therapeutic areas are executed in...
-
Clinical Operations Specialist
hace 1 mes
Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo**About the Role**Worldwide Clinical Trials is seeking a highly organized and detail-oriented Clinical Operations Specialist to join our team. As a Clinical Operations Specialist, you will be responsible for carrying out daily aspects of operational work related to rater selection, rater certification/qualification, rater training content, scale acquisition,...
-
Clinical Trials Senior Analyst
hace 4 semanas
Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completoAre you passionate about clinical trials and ensuring compliance with Mexican importation and exportation laws? We are looking for a Clinical Trials Senior Analyst to join our team at Novo Nordisk A/S in Mexico. If that sounds like you, read on to learn more about this exciting opportunity.The PositionAs a Clinical Trials Senior Analyst, you will be...
-
Clinical Trials Senior Analyst
hace 1 mes
Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completoAre you passionate about clinical trials and ensuring compliance with Mexican importation and exportation laws? We are looking for a Clinical Trials Senior Analyst to join our team at Novo Nordisk in Mexico.The PositionAs a Clinical Trials Senior Analyst, you will be responsible for:Ensuring compliance with importation and exportation laws, maintaining close...
-
Clinical Trials Specialist
hace 4 días
Ciudad de México, Ciudad de México SAO Fortrea Brazil Limitada A tiempo completoAt SAO Fortrea Brazil Limitada, we're dedicated to transforming drug and device development for partners and patients worldwide. As a Clinical Trials Specialist - Central Monitoring Associate, you'll play a vital role in ensuring the timely execution of central monitoring activities.Job Description:The ideal candidate will possess a university/college degree...
-
Clinical Research Manager
hace 1 mes
Ciudad de México, Ciudad de México MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completoAbout the RoleMEX Labcorp Clinical Development, S. de R.L. de C.V. is seeking a highly motivated and experienced Clinical Research Manager to join our team. As a key member of our clinical operations team, you will be responsible for managing clinical trials from feasibility to close-out, ensuring timely and efficient execution of studies.Key...
-
Clinical Trials Supplier Manager
hace 3 semanas
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoWork ScheduleStandard hours of work (Monday to Friday) in a typical office environment.Job DescriptionWe're seeking a skilled Clinical Trials Supplier Manager to support our day-to-day operations. You will be responsible for managing study drug, comparators, and ancillaries, ensuring all activities are completed in compliance with company good practices and...
-
Clinical Trials Project Coordinator
hace 4 semanas
Ciudad de México, Ciudad de México IQVIA A tiempo completoClinical Trials Project CoordinatorJob OverviewLeads and oversees the execution of clinical projects and research studies in accordance with global and local regulations to best meet customer needs while working toward organizational goals and strategies.Provides project-related support to the project management teams of assigned clinical research studies....
-
Clinical Research Associate
hace 3 semanas
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoClinical Research Associate Job DescriptionPurpose:Clinical Research Associate (CRA) Job SummaryWe are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our team. The CRA will be responsible for monitoring and coordinating clinical trials, ensuring compliance with regulatory requirements and Good Clinical Practice (GCP)...
-
Senior Clinical Trials Specialist
hace 4 días
Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completoWe are seeking a Senior Clinical Trials Specialist to join our team in Mexico.About the RoleThe Senior Clinical Trials Specialist will be responsible for ensuring compliance with importation and exportation laws, maintaining close communication with CDC TMs, anticipating potential risks, and safeguarding company resources.Key ResponsibilitiesBe the main...
-
Clinical Research Associate
hace 4 días
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoJob SummaryWe are seeking a highly skilled Clinical Research Associate to join our team. As a CRA, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the conduct of clinical trials.