Clinical Operations Manager
hace 4 semanas
Job Description
This position is responsible for ensuring performance and compliance for assigned protocols in a specific country, adhering to ICH/GCP and country regulations, company policies, quality standards, and adverse event reporting requirements both internally and externally. Under the guidance of the Head COMs, the individual will oversee the execution of clinical trial country submissions, approvals, and readiness of sites. Key responsibilities include, but are not limited to:
- Executing and overseeing clinical trial country submissions and approvals for assigned protocols.
- Developing local language materials, such as Informed Consents and translations, and collaborating with IRB/IEC and Regulatory Authority.
- Managing country deliverables, timelines, and results to fulfill commitments and ensure quality and compliance.
- Contributing to the development of local SOPs and overseeing CTCs where applicable.
- Coordinating with internal teams and external partners to obtain necessary country deliverables and aligning timelines.
- Providing support and oversight to local vendors and overseeing various local processes.
- Owning local regulatory and financial compliance to support successful trial outcomes.
- Directly and indirectly influencing stakeholders and maintaining budget targets and payment timelines.
- Collaborating internally and externally to drive initiatives and projects that enhance business value.
- Sharing expertise and best practices with the team, acting as a Subject Matter Expert and providing mentorship.
Secondary Language(s) Job Description:
Core competencies:
- Expertise in core clinical systems, tools, and metrics.
- Strong verbal and written influencing, training, and mentoring skills in local language and English.
- Effective coordination, organizational, and submission/approval process knowledge.
- Ability to proactively address issues, lead a team, and make independent decisions.
- Thorough understanding of the local regulatory environment and development of risk management plans.
Behavioural Competency Expectations:
- Efficient problem-solving skills and time management.
- Accountability, urgency, and strong communication/leadership skills.
- Focus on multiple deliverables simultaneously, even in a remote setting.
- Positive and growth mindset with the ability to influence site staff directly.
Experience Requirements:
Required: 5 years of experience in clinical research or related field.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Materials:
NoJob Posting End Date:
06/06/2024*Note: Job postings are effective until 11:59:59PM on the day BEFORE the listed end date. Please ensure timely application submission.
Requisition ID: R292868
-
Clinical Research Manager
hace 4 semanas
Ciudad de México, Ciudad de México MSD A tiempo completoJob DescriptionOur Clinical Research and Pharmacovigilance team strives to advance global healthcare through groundbreaking research and innovation. By conducting clinical trials and surveillance, we guarantee the safety and effectiveness of our current and upcoming products, producing cutting-edge, secure, and effective medications.Essential Knowledge in...
-
Clinical Research Manager
hace 1 semana
Ciudad de México, Ciudad de México MSD A tiempo completoJob DescriptionOur Clinical Research and Pharmacovigilance team strives to advance global healthcare through groundbreaking research and innovation. By conducting clinical trials and surveillance, we guarantee the safety and effectiveness of our current and upcoming products, producing cutting-edge, secure, and effective medications.Essential Knowledge in...
-
Clinical Research Associate
hace 2 semanas
Ciudad de México, Ciudad de México MSD A tiempo completoJob DescriptionThe 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.Acts...
-
Clinical Research Associate
hace 1 semana
Ciudad de México, Ciudad de México MSD A tiempo completoJob DescriptionThe 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 company policies and procedures, quality standards and adverse event reporting requirements internally and...
-
Clinical Research Associate
hace 1 semana
Ciudad de México, Ciudad de México MSD A tiempo completoJob DescriptionThe 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.Acts...
-
Operations Manager
hace 3 semanas
Ciudad de México, Ciudad de México Netflix A tiempo completoAbout Netflix: Netflix is a global powerhouse in streaming entertainment, with over 260 million paid memberships spanning 190+ countries. Our members enjoy a diverse array of TV series, documentaries, feature films, and mobile games, all available on-demand and across various genres and languages.About the Team: The Scaled Launch Operations team forms part...
-
Operations Manager
hace 1 semana
Ciudad de México, Ciudad de México Netflix A tiempo completoAbout Netflix: Netflix is a global powerhouse in streaming entertainment, with over 260 million paid memberships spanning 190+ countries. Our members enjoy a diverse array of TV series, documentaries, feature films, and mobile games, all available on-demand and across various genres and languages.About the Team: The Scaled Launch Operations team forms part...
-
Sr. Operations Manager BPO
hace 2 meses
Ciudad de México, Ciudad de México Concentrix A tiempo completoJob Title:Sr. Operations Manager BPO - CDMXJob DescriptionThe Sr. Operations Manager is responsible for:Strategic Oversight: Lead and execute operational strategies, manage resources, and optimize processes to achieve organizational goals and enhance efficiency.Team Leadership and Quality Control: Direct a team, ensure product/service quality, manage...
-
Sr. Operations Manager BPO
hace 1 semana
Ciudad de México, Ciudad de México Concentrix A tiempo completoJob Title:Sr. Operations Manager BPO - CDMXJob DescriptionThe Sr. Operations Manager is responsible for:Strategic Oversight: Lead and execute operational strategies, manage resources, and optimize processes to achieve organizational goals and enhance efficiency.Team Leadership and Quality Control: Direct a team, ensure product/service quality, manage...
-
Senior Clinical Trial Coordinator
hace 3 semanas
Ciudad de México, Ciudad de México MSD A tiempo completoJob DescriptionThis role is responsible for comprehensive trial and site administration. Under the oversight of the Senior COM or COMs or CTC Manager, the person prepares, collates, distributes and archives clinical documents.The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as...
-
Senior Clinical Trial Coordinator
hace 1 semana
Ciudad de México, Ciudad de México MSD A tiempo completoJob DescriptionThis role is responsible for comprehensive trial and site administration. Under the oversight of the Senior COM or COMs or CTC Manager, the person prepares, collates, distributes and archives clinical documents.The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as...
-
Clinical Implementation Manager
hace 2 meses
Ciudad de México, Ciudad de México bioMérieux A tiempo completoClinical Implementation Manager - MéridaEstamos en la búsqueda de un Representante de Ventas de Alto Valor Médico quien trabajará y crecerá dentro del Área Comercial, reportando directamente al Gerente Comercial de la zona norte, dentro de un equipo de 9 personas. Esta posición estará basada en la ciudad de Mérida, Yucatán El Representante de...
-
Clinical Implementation Manager
hace 1 semana
Ciudad de México, Ciudad de México bioMérieux A tiempo completoClinical Implementation Manager - MéridaEstamos en la búsqueda de un Representante de Ventas de Alto Valor Médico quien trabajará y crecerá dentro del Área Comercial, reportando directamente al Gerente Comercial de la zona norte, dentro de un equipo de 9 personas. Esta posición estará basada en la ciudad de Mérida, Yucatán El Representante de...
-
Associate Clinical Research Associate
hace 1 semana
Ciudad de México, Ciudad de México MSD A tiempo completoJob DescriptionWith support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.• Performs clinical study site...
-
Technology Operations, Sr Manager
hace 4 semanas
Ciudad de México, Ciudad de México teamworkonline A tiempo completoReporting functionally to the Director Event Technology Operations and organisationally to the Chief Tournament Officer in Mexico, the Senior Manager of Technology Operations, Mexico will be a key member of the FIFA26 Technology team, and work in close collaboration with the Technology teams in Zurich and other key individuals responsible for the planning,...
-
Technology Operations, Sr Manager
hace 1 semana
Ciudad de México, Ciudad de México teamworkonline A tiempo completoReporting functionally to the Director Event Technology Operations and organisationally to the Chief Tournament Officer in Mexico, the Senior Manager of Technology Operations, Mexico will be a key member of the FIFA26 Technology team, and work in close collaboration with the Technology teams in Zurich and other key individuals responsible for the planning,...
-
Senior Manager, Guest Operations
hace 3 semanas
Ciudad de México, Ciudad de México teamworkonline A tiempo completoSitting within the Operational Services Department in México, Guest Operations (along with Accommodation, Transport, Logistics, Travel, and Arrivals and Departures) aims to deliver the most engaging, innovative, and accessible World Cup experience for all athletes, fans, partners, and the community. Reporting organizationally to the Head of Guest Operations...
-
Senior Manager, Guest Operations
hace 1 semana
Ciudad de México, Ciudad de México teamworkonline A tiempo completoSitting within the Operational Services Department in México, Guest Operations (along with Accommodation, Transport, Logistics, Travel, and Arrivals and Departures) aims to deliver the most engaging, innovative, and accessible World Cup experience for all athletes, fans, partners, and the community. Reporting organizationally to the Head of Guest Operations...
-
Operations Specialist, French
hace 2 semanas
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob OverviewReview, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team...
-
Operations Specialist, French
hace 1 semana
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob OverviewReview, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team...