Clinical Project Manager

hace 6 meses

Ciudad de México Novartis A tiempo completo

392018BR

**Clinical Project Manager**:
Mexico

**About the role**

**Work Model**:Hybrid
**Locality**:Ciudad de Mexico

**About the Role**:
The SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from first site initiation visit to and including study site close-out), of assigned Global Drug Development (GDD) studies in assigned geographies in compliance with Novartis processes and regulatory requirements.
The CPM is the single point of contact and study team lead, within the country/cluster/hub, for the assigned studies and countries. The CPM is responsible for assuring aligned communication with Trial Lead and other CTT members, locally with Clinical Research Associates (CRAs), CRA Managers and other key associates on the execution and progress of their studies in all assigned countries. The CPM collaborates with the SSO Country Manager, SSO Country Head, SSO Feasibility Manager, SSO Study Start-up Manager and SSO Site Partnership Manager and other local stakeholders in the planning, execution, and delivery of their assigned studies in assigned geographies. The CPM represents the voice of the cross-border community in assigned countries in the CTT. The CPM is accountable for execution and reporting of assigned GDD studies in E2E product line Clinical Operations Program Head/Study Lead/ CPM - CRA. Can be assigned partially to participate in the review process of Site Monitoring Plans across Portfolio.
**Key responsibilities**:

- Supports SSO Study Start-up Manager in the development of country/cluster/hub study execution plans and timeline commitments
- Participates in the recruitment sub-team and supports the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time
- Proactively identifies risk and opportunities for the assigned studies within the country/cluster/hub and develops respective mitigation plans

Initiation and conduct of trials
- When requested by the SSO Feasibility Manager supports the study feasibility by providing input to the study protocol, and operational aspects of the study
- Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites and Country/Cluster/Hub personnel
- Drives the conduct of the study, (tracks status, maintains relevant reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track
- Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for getting approval from the STUDY LEADER on enrolling above site targets. Responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan.

Oversees local study team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and relevant regulations
- Leads/chairs country/cluster/hub study team meetings, participates in global clinical trial team meetings, as required and is the single point of contact for the conduct of assigned studies
- Maintains oversight of country/cluster/hub level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues
- Coordinates the study handover process with CRAs and their managers to ensure proper documentation and communication, when necessary
- Tracks that all study close-out activities are performed in a timely manner, in collaboration with CRAs and key study stakeholders

Delivery of quality data and compliance to quality standards
- Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
- Conducts or coordinates local investigator meetings as needed and ensures relevant documentation of training is archived in the Trial Master File
- Evaluates potential challenges/risks within the protocol and operational aspects of the study; assessing impacts, develops risk management plans and communicates/ escalates to global teams and SSO Hub Head Portfolio, as appropriate
- Accountable for monitoring quality and issue resolution through timely review and approval of study monitoring visit reports to ensure quality trial oversight and appropriate issue escalation
- Escalation point for issues in monitoring visit reports (MVRs) for the assigned studies. Responsible for evaluating trends identified in MVRs and communicating/escalating to global teams, as appropriate. Communicates with CRAs and their managers to ensure issue resolution in a timely manner
- Provides feedback about the quality of moni

  • Clinical Trials Project Manager

    hace 2 semanas

    Ciudad de México, Ciudad de México IQVIA A tiempo completo

    Job 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 Trials Operations Manager

    hace 24 horas

    Ciudad de México, Ciudad de México MEX Fortrea Clinical Development Mexico A tiempo completo

    **About MEX Fortrea Clinical Development Mexico**: We are a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. Our team provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions...

  • Clinical Trial Manager Focus Project Management

    hace 3 meses

    México, Méx. Syneos - Clinical and Corporate - Prod A tiempo completo

    **Description** **Clinical Trial Manager focus Project Management sponsor dedicated-Home Based Mexico** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our...

  • Clinical Trial Operations Manager

    hace 1 mes

    Ecatepec de Morelos, México Syneos Health Clinical A tiempo completo

    **Clinical Trial Management Role**At Syneos Health Clinical, we are seeking a skilled Clinical Trial Manager to oversee site management, clinical monitoring, and central monitoring deliverables for our clients. As a Clinical Trial Manager, you will be responsible for ensuring patient safety, protocol/GCP/regulatory compliance, and data integrity.**Key...

  • Clinical Trial Manager Any Therapeutic

    hace 6 meses

    Edo. de México Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager any therapeutic area-assigned to client Mexico** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to...

  • 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 completo

    Job 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 Trials Project Coordinator

    hace 1 mes

    Ciudad de México, Ciudad de México IQVIA A tiempo completo

    Clinical 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 Supplies Project Manager

    hace 5 meses

    Ciudad de México ICON plc A tiempo completo

    **Clinical Supplies Project Manager** ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we...

  • Clinical Project Manager

    hace 5 meses

    Ciudad de México Novartis A tiempo completo

    The SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from first site initiation visit to and including study site close-out), of assigned Global Drug Development (GDD) studies in compliance with Novartis processes and regulatory requirements. The CPM is the single point of contact and study team lead,...

  • Senior Clinical Project Coordinator

    hace 2 semanas

    Ciudad de México, Ciudad de México IQVIA A tiempo completo

    Salary: $80,000 - $110,000 per yearAbout the RoleWe are seeking a highly skilled Senior Clinical Project Coordinator to join our team at IQVIA in Mexico City. As a key member of our clinical project team, you will play a crucial role in leading and overseeing the execution of clinical projects and research studies.Key Responsibilities:Provide project-related...

  • Senior Clinical Project Manager, Internal Medicine

    hace 5 meses

    Ciudad de México Novasyte A tiempo completo

    POSITION TITLE: Senior Project Manager REPORTS TO: Director, Project Management or Designee BASIC FUNCTIONS: Responsible for the successful planning, implementation and execution of contracted activities. Assures the accurate transfer of contracts from proposal through project completion. Functionally responsible for all team members throughout the...

  • Clinical Trial Manager with Regional and Usa/canada

    hace 6 meses

    Edo. de México Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager any therapeutic area-Home based LATAM** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and...

  • Clinical Trial Manager With Regional And Usa/Canada Experience

    hace 1 mes

    Ecatepec de Morelos, México Syneos Health Clinical A tiempo completo

    **Clinical Development Expertise**Syneos Health Clinical is seeking a skilled Clinical Trial Manager to oversee site management, clinical monitoring, and central monitoring deliverables. This role requires a strong focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.**Key Responsibilities**Responsible for site management...

  • Clinical Project Lead

    hace 1 semana

    Ciudad de México, Ciudad de México ESTERN Medical LLC A tiempo completo

    Job Title: Clinical Project LeadJob Summary:We are seeking a highly experienced Clinical Project Lead to join our team at ESTERN Medical LLC. In this role, you will be responsible for the successful conduct of assigned international projects, Phase I, II, III, and IV, for Pharmaceutical & Medical Device projects, according to ESTERN Medical Standard...

  • Project Mgr/senior Project Mgr, Global Clinical

    hace 6 meses

    Ciudad de México Thermo Fisher Scientific A tiempo completo

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...

  • Senior Clinical Project Manager Internal Medicine Leader

    hace 3 semanas

    Ecatepec de Morelos, México Sc Johnson A tiempo completo

    Senior Clinical Project Manager Internal Medicine RoleAs a Senior Clinical Project Manager Internal Medicine Leader, you will collaborate with a wide array of teams to help our clients implement and operate new capabilities. BASIC FUNCTIONS:Responsible for the successful planning, implementation and execution of contracted activities. Senior Project Manager...

  • Clinical Project Lead

    hace 1 mes

    Ciudad de México, Ciudad de México IQVIA A tiempo completo

    Job OverviewClinical Project Leads play a vital role in the delivery of clinical trials, collaborating with clinical teams to accelerate the development of new drugs. As an integral part of the core project team, this role is responsible for ensuring the successful delivery of clinical studies in accordance with contractual requirements, SOPs, policies, and...

  • Project Mgr/senior Project Mgr, Global Clinical

    hace 6 meses

    Ciudad de México Thermo Fisher Scientific A tiempo completo

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...

  • Clinical Project Manager, Dermatology, Home-based

    hace 5 meses

    Ciudad de México Novasyte A tiempo completo

    PLEASE SUBMIT RESUMES IN ENGLISH. BASIC FUNCTIONS: Responsible for the successful planning, implementation and execution of contracted activities. Assures the accurate transfer of contracts from proposal through project completion. Functionally responsible for all team members throughout the duration of each clinical trial. Assures clear client...

  • Clinical Development Manager

    hace 4 semanas

    Ecatepec de Morelos, México Syneos Health Clinical A tiempo completo

    About UsSyneos Health Clinical is a leading biopharmaceutical solutions organization that accelerates customer success.We are a fully integrated company purpose-built to provide high-value insights that speed therapies to patients.Our ApproachWe lead with a product development mindset, seamlessly connecting our capabilities to simplify and streamline our...