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Claudia Rodas

Contact Claudia Rodas
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Career Profile

Degree: Bachelor's Degree
Career Level: Fully Competent
Occupation: Healthcare
Target Title: Clinical, Clinical Research
Skills: Manager;Clinical Research;CRA Clinical Research Associate;
Claudia Rodas is Clinical, Clinical Research(Healthcare) from Guatemala,Guatemala Guatemela.

Experience


MSD-Merck Guatemala, Guatemala Guatemela
Industry: Pharmaceutical Clinical Research Industry
06/2014 - 09/2016
Clinical Operations Manager for Central America, Panama and Dom. Republic
Clinical Operations Management. Accountable for execution and oversight of local operational clinical trial activities in the country
Clinical Operations Management. Accountable for execution and oversight of local operational clinical trial activities in the country for assigned protocols in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Focus on and support audit ready mindset in daily duties. • Country submissions and local language materials. Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language informed consents and translations. Interactions with IRB/EC and Regulatory Authority for assigned protocols. • Management & Quality Oversight. Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country. Contributes in the development of Local SOPs. • Local process oversight. Oversight and coordination of local processes. Clinical and ancillary supplies management, in-and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical tracking systems.
MSD - MERCK Guatemala, Guatemala Guatemela
Industry: Pharmaceutical Clinical Research Industry
06/2010 - 05/2014
Clinical Project Manager for Central America, Panama and Dom. Republic
Responsible for project deliverables and performance in assigned protocols according to ICH/GCP, country regulations, company policies and processes and quality standards, oversight of Validation, Site Selection, Site Ready,
Responsible for project deliverables and performance in assigned protocols according to ICH/GCP, country regulations, company policies and processes and quality standards, oversight of Validation, Site Selection, Site Ready, ongoing and close out phases. Be the primary point on contact between HQ and Country Operations. Attend protocol international meetings. • Responsible for meeting country targets and objectives for assigned protocols. Drives and tracks protocol deliverables, timelines, trends and performance to meet regional commitments, identify risks and issue escalation process. Budget negotiations with sites. Oversight/review and follow up of KPIs, metrics, country dashboards. • • Support In House QC Plan, CENAM SOP committee strategies, Change Personal Info E-mail ccristinaillescas@gmail.com Date of birth 1977-12-21 Skills Clinical Research Management Expert Honor and Date Shining Performance. Change Agent Network. 2013. Honor and Date Shining Performance. Change Agent Network. 2012. Honor and Date Shining Performance. Clinical Research Associate performance. 2008. Honor and Date The Most Active CTMS User in the World 2001. Course/Date Good Clinical Practice. GCTO Latin America - Clinical Operations Managers Training Meeting - Peru. 2016. Course/Date GCP. I & II Clinical Research Congress. 2013 - 2014. Course/Date Core Team - Lean Kaizen - Regional TMF Optimization 2012. Phone: 502-3255-8146 502-4877-1747 Agent Initiative which consists in being the CENAM region representantive for being the POC of employees for having their consultations/issues to have them consolidated and listened by CRD and support the coordination of an effective support and resolution. Contributes in the development of Local SOPs. • Support the audits preparation, execution, CAPA resolution. Responsible for performing validations visits, protocol sites visits to ensure protocol, ICH/GCP and company requirements compliance, and support with QC Visits.
MSD - MERCK - Schering Plough Guatemala, Guatemala Guatemela
Industry: Pharmaceutical Clinical Research Industry
06/2008 - 05/2010
Clinical Research Associate for Central America, Panama and Dom. Republic
Responsible for the effecive protocol execution at study sites. Being the POC between the site and the company.
Clinical Research Associate for Central America, Panama and Dom. Republic Responsible for the effecive protocol execution at study sites. Being the POC between the site and the company. Perform validation, monitoring visits (site initiation, ongoing and close out visits) to ensure protocol compliance, ICH/GCP, country regulations, company procedures and quality standards and adverse events reporting.

Education


UG Guatemala, Guatemala, Guatemela
01/2012 - 06/2015
Degree: Bachelor's Degree
Major:Clinical Investigation
Health Care

Resume(verified employer only)

Claudia Rodas Clinical Research Expertee

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