RTL888 - Director, Clinical Operations (Mexico)

RTL888 - Director, Clinical Operations (Mexico)

Get AI-powered advice on this job and more exclusive features.Overview Of RoleThe 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 Mexico in alignment with global strategy.Role And ResponsibilitiesAccountable 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.All other duties as assigned.Experience, Education And Specialized Knowledge And SkillsBA/BS required; in a scientific/medical field preferred.
Advanced degree preferred.A minimum of 10+ years industry or related experience.Extensive early/late-stage drug development oncology experience ideally including time in role such as a Local or Global Study Leader.Knowledge and experience of drug development in Mexico region.Proven line and performance management experience; functional management experience,



managing resourcing and budget planning and oversight.Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment.Proven organization design and change management experience.Excellent written and verbal communication skills.Proven ability to develop successful collaborations with internal and external partners.Seniority levelDirectorEmployment typeFull-timeJob functionStrategy/Planning and Information Technology
#J-18808-Ljbffr

El anuncio original lo puedes encontrar en Kit Empleo:
https://www.kitempleo.com.mx/empleo/135592044/rtl888-director-clinical-operations-mexico-xico/?utm_source=html