Lizbeth Olvera Email & Phone Number

Mexico City, Mexico

México

• Develops Contracts and budget plan, to outline the CTA/Budget negotiation process and responsibilities between CRO/Sponsor• Provides to Site Contracts Specialist Master CTA/BGTs templates, and collaboratively ensures all modifications from the masters are cascaded into country, regional or site-specific templates• Supervises and mentors allocated Site Contracts Specialist• Ensures effective planning, develops/finalizes final contracting templates• Monitors/escalates site activation risks• Maintains system tools up to date, and works to ensure timely execution of Contracts• Responsible to supervise and negotiate CTA/BGT escalations with Sponsor• Works closely with the regulatory department to ensure delivery of fully executed agreements in support of timely study site activation deliverables to meet departmental goals. • Responsible of second Quality Control of CTAs/BGTs, prior to signatures• Requests Site Contracts Specialists resources assignment, responsible to review and approve such time while the term of the study • Attend Sponsor meetings, as required, presenting status, timelines and raise any risks that could potentially impact site activation dates• Responsible to report actual fully executed units performed and review the forecast for the rest of the project and make any necessary updates • Review and report Out of Scope units performed or planned to be performed that are not currently included in the latest Work Order for a project

México

México

Responsible for the development, dissemination, negotiation and finalization of clinical study and investigator agreements and related documents between sponsors and clinical research sites. • Over 7 years of experience as Contract negotiator of Clinical Trial Studies • Experience in Contract and budget negotiation in LatAm, USA, Central America and Caribbean.• Drafting, review and analysis site, investigator and other project-related Agreements.• Negotiation and finalization of Clinical Trial Agreements and services contracts with Legal Department, study team, Sponsors, investigators and/or clinical sites, amending and terminating such agreements according to sponsor’s guidelines and fallbacks. • Development and negotiation or assistance in new country Contract templates. • Manage execution (including signature process) of Clinical Trial Agreements. • Review of study budgets and costs pertaining to contract negotiation.• Representation of the Company in relations with Clinical Trial Agreements and project-related vendors, as applicable.• Performing legal translation and/or proofreading of contracts with clinical sites/investigators.• Develop, monitor, track and process new and amended investigator/site contracts and other project-related agreements.• Review contracts and other documents for completeness and accuracy.• Maintain and update hard-copy and electronic contract files.• Development of strategies to manage the workload of Clinical Trial Agreements.

Ciudad De México, Distrito Federal, México

Cidade Do México E Região, México

• 5.5 years of experience working in clinical research with 5.5 of years of experience working in site activation.• Over 4.5 years of experience as Contract negotiator of Clinical Trial Studies.• Negotiation, review and implementation of appropriate Clinical Trial Agreements and Budgets Contract and budget negotiation for studies on start up• Budget negotiation and follow up of sites requests according to sponsor’s negotiation parameters and guidelines• Contracts negotiation and follow up of sites request according to sponsor’s guidelines and fallbacks • Quality control of final version of Budgets and Contracts • Straight communication with Legal department for specific requirements and legal terms • Creation and development of tools for Subject Matter Experts Contracts Latam team• Experience in Contract and budget negotiation in Central America and Caribbean• Experience to evaluate and project milestones for planned dates, updated and compliance with the in the systems and witting the teams • Review of Pre Study Visits regarding contract and budget site’s request • Negotiation and implementation of Budget Amendments, Contract Amendments, Start-up fee letters, Transfer agreement, Termination of Agreements, etc.• Communication with Principal Investigators, Sites, Sponsors and internal team regarding development/status of contracts, budgets, legal requisitions • Develop of final versions CTAs for Quality Check prior signatures process • Performance evaluation of contracts training and plan of skills development • Development of a strategy to manage a high workload of Investigator Contracts• Report and support to Study Start Up Leads including tracking, filing and other coordinating tasks related Contracts and budgets • Collection and follow up of legal documents and beneficiary details with sites for CTAs drafting• Administrative execution activities, translations process, invoices payments regarding contracts

México

• Reception and review of official documentation• Scheduling and assistance of professional examination• Population official documentation for certification degree