[UIN092] Director, Clinical Operations (Mexico)

[UIN092] Director, Clinical Operations (Mexico)

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**Overview of Role**:The Director, Clinical Operations Mexico, is accountable for providing leadership and operational expertise into execution of one or more phase 1-3 clinical trials conducted in Mexico.
The role will be part of the Global Clinical Operations (GCO) group reporting into USA VP, Head of Clinical Operations.
This position is expected to:- Collaborate with Contract Research Organization (CROs) and identify, champion, and implement key improvements in the outsourced operating model for optimization, performance, and site engagement- Strategize local needs and help build resource needs to support the clinical trial delivery strategy in an effective, efficient,



and compliant manner- Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders- Lead and inform the direction & strategy for a potential insourced clinical trial model for the Mexico in alignment with global strategy**Role and Responsibilities**:- Accountable to lead, manage and drive operational excellence in Mexico.
This will be accomplished through CRO delivery and considerations of future internalization of GCO's operating model where appropriate.- Responsible for operational deliverables in Mexico in accordance with time, cost, and quality commitments- Function as a key point of escalation for issues and problem resolution impacting new and ongoing studies to ensure business critical milestones are achieved for Mexico- In accordance with the global strategy and pace, support the creation and direct on a Mexico regional strategy including resource requirements and capabilities needed- Build strong relationships with Summit Study Leads and Study Cross-Functional Teams.




They will leverage this information to help guide in operational direction of disease area expertise and country specific expertise specific to Mexico needs.- Feasibility:- Understands and highlights country specific strength and opportunities in the creation of the strategy for selection of countries/sites for Mexico- Ensures timely inclusion of robust regional/country-level insights and feasibility outcomes into the operational plans to enable effective and efficient delivery to plan- In partnership with the global study team, maintains Mexico risks, proactively communicates progress, issues or changes that may impact timelines and costs.
Identifies trends & patterns across study and program level and supports mitigation and prevention of Mexico specific systemic issues and risks.- Accountable for the study level quality, and compliance with GCP,



local laws and regulations and guide the team with local HA inspection readiness- Line management of regional team in line with business needs.
This may include but not limited to GCO roles in the following areas - study management, site engagement, and/or other local staff working from the Mexico region

El anuncio original lo puedes encontrar en Kit Empleo:
https://www.kitempleo.com.mx/empleo/134121066/uin092-director-clinical-operations-mexico-nuevo-casas-grandes/?utm_source=html