Clinical Operations Manager
hace 2 semanas
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Under the oversight of the Sr.COM, Head COMs or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.
Responsibilities include, but are not limited to:
- Executes and oversees clinical trial country submissions and approvals for assigned protocols
- Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols
- Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country
- Contributes to the development of local SOPs. Oversees CTCs as applicable
- Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Headquarter to align country timelines for assigned protocols
- Provide support and oversight to local vendors as applicable
- Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
- Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver countryspecific trial commitments and objectives especially during study startup
- Required to in/directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines
- Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval relatedinteractions
- Contribute or lead initiatives and projects adding value to the business, as appropriate/required
- Contributes strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required
- Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.
Search Firm Representatives Please Read Carefully
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
06/11/2024
Job Posting End Date:
06/11/2024
Requisition ID:
R296903
-
Clinical Operations Manager
hace 4 semanas
Santiago, Metropolitana, Chile MSD A tiempo completoJob DescriptionThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...
-
Clinical Operations Manager
hace 2 semanas
Santiago, Metropolitana, Chile MSD A tiempo completoJob DescriptionThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...
-
Clinical Operations Manager
hace 4 semanas
Santiago, Metropolitana, Chile MSD A tiempo completoJob DescriptionThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...
-
Operations Manager
hace 2 semanas
Santiago, Metropolitana, Chile Flix Se A tiempo completoInicio Trabajos para Operations Manager en la Chile 2 Trabajos para Operations manager en la Chile Project Manager Operations ermanen DIPREM GLOBAL Descripción del puesto Para compañía líder nos encontramos en la búsqueda de un Project Manager Operations . Será responsable por garantizar la ejecución de las tareas directas e indirectas asocia... Leer...
-
Clinical Research Associate
hace 2 semanas
Santiago, Metropolitana, Chile MSD A tiempo completoJob Description:The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally....
-
Marketing Clinical Diagnostics LATAM Manager
hace 2 semanas
Santiago, Metropolitana, Chile Grifols A tiempo completoDo you want to be part of a global team dedicated to enhancing healthcare? Grifols, a leading healthcare company founded in Barcelona in 1909, is committed to improving the well-being of individuals worldwide through innovative medicines and services across 100+ countries.We value diversity as a driving force for our business, teams, and culture, promoting...
-
Operations Manager
hace 2 semanas
Santiago, Metropolitana, Chile NovaSource Power A tiempo completoObjective:This position reports to the Director LATAM operations and is expected to lead operations and maintenance services in Chile.Continue to create and expand services meeting and exceeding KPI and expectations.Responsible for operations and maintenance sites creating value through optimize resources and increasing the productivity.Leading and adapting...
-
Marketing Clinical Diagnostics Latam Manager
hace 2 semanas
Santiago, Metropolitana, Chile Grifols Chile SA A tiempo completoDo you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic,...
-
Field Clinical Representative
hace 2 semanas
Santiago, Metropolitana, Chile Boston Scientific Corporation A tiempo completoField Clinical Representative - Endo - Chile:Work mode: Field BasedTerritory: ChileDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, you have the chance to unlock your full potential by collaborating with a diverse team of top-notch employees, taking on vital challenges in the healthcare industry....
-
Clinical Research Manager
hace 2 semanas
Santiago, Metropolitana, Chile MSD A tiempo completoJob DescriptionThis role is primarily accountable for the end to end performance for assigned protocols in a country in compliance and regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.The CRM could be responsible for a particular study for several countries in a...
-
Clinical Research Manager
hace 4 semanas
Santiago, Metropolitana, Chile MSD A tiempo completoJob DescriptionThis role is primarily accountable for the end to end performance for assigned protocols in a country in compliance and regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.The CRM could be responsible for a particular study for several countries in a...
-
Operations Manager
hace 2 semanas
Santiago, Metropolitana, Chile Eficazmente - Grupo Tca A tiempo completoPublicada ayer por - EFICAZMENTE GRUPO TCA JornadaCompleta Gerente Estados Unidos NJ Thesuccessful Operations Manager will oversee the entering supply offresh fruit in to the warehouse cooler (NJ, USA) to our clients. Thismanager collaborates with crossfunctional teams to procure freshwithin budget, time limit and achieve KPIs. The role involves...
-
Array and Operations Performance Group Manager
hace 2 semanas
Santiago, Metropolitana, Chile Associated Universities, Inc. A tiempo completoALMA Vacancy Notice:The Atacama Large Millimeter/submillimeter Array (ALMA), an international astronomy facility, is a partnership of the European Organization for Astronomical Research in the Southern Hemisphere (ESO), the U.S. National Science Foundation (NSF) and the National Institutes of Natural Sciences (NINS) of Japan in cooperation with the Republic...
-
Field Clinical Specialist
hace 2 semanas
Santiago, Metropolitana, Chile Boston Scientific Corporation A tiempo completoWork mode:HybridTerritory:ChileAdditional Locations: N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and highperforming employees, tackling some of the most important health industry challenges....
-
Clinical Research Project Manager
hace 2 semanas
Santiago, Metropolitana, Chile Thermo Fisher Scientific A tiempo completoCustomers globally rely on our extensive range of products and services—from life-saving medicines to lab essentials to next-generation instruments. Our Operations team leverages our PPI (Practical Process Improvement Business System) to manufacture and produce these products and continuously improve productivity and quality all while contributing to our...
-
Product Operations Supervisor
hace 2 semanas
Santiago, Metropolitana, Chile Toku A tiempo completoInicio Trabajos para Product Operations Supervisor en... 1 Trabajos para Product operations supervisor en la Chile Product Operations Supervisor Toku Hoy Estamos en búsqueda del mejor Product Operations Manager para nuestro equipo de Operaciones. Debe ser alguien que se sienta cómodo en un ambiente ágil y dinámico, capaz de realizar análisis detalla......
-
Regional Operations Manager
hace 2 semanas
Santiago, Metropolitana, Chile Boart Longyear A tiempo completoSantiago, Chile Reqid: 14931BR Job Category:GDSAt Veracio, we're unlocking the value and utility of scarce resources, and it all starts with the orebody. Whether that's unlocking hard-to-find minerals that are critical for a sustainable future. Or liberating time through the automation workflows from exploration through to production geoscience. Or the...
-
Array and Operations Performance Group Manager
hace 2 semanas
Santiago, Metropolitana, Chile National Radio Astronomy Observatory A tiempo completoNational Radio Astronomy ObservatoryALMA Vacancy NoticeThe Atacama Large Millimeter/submillimeter Array (ALMA) is looking for a talented individual to join their team as the Array and Operations Performance Group Manager. ALMA is an international astronomy facility that collaborates with organizations like ESO, NSF, and NINS. If you have a passion for...
-
Farm Operations Manager
hace 2 semanas
Santiago, Metropolitana, Chile TIAA A tiempo completoThe Agronomist Role in Chile at NNCThe Agronomist will oversee all farming operations of the horticulture portfolio managed by NNC in Chile. This role involves acting as a trusted advisor and ensuring the proper management of farming operations conducted by third-party crop managers. NNC Chile is currently experiencing growth, requiring a candidate with...
-
Array and Operations Performance Group Manager
hace 2 semanas
Santiago, Metropolitana, Chile Associated Universities, Inc. A tiempo completoALMA Vacancy Notice The Atacama Large Millimeter/submillimeter Array (ALMA), an international astronomy facility, is a partnership of the European Organization for Astronomical Research in the Southern Hemisphere (ESO), the U.S. National Science Foundation (NSF) and the National Institutes of Natural Sciences (NINS) of Japan in cooperation with the Republic...