Corporate Law Attorney with 18 years of comprehensive experience in the Clinical Research Organization (CRO) industry. Expertly manages the global clinical research contracts process, ensuring compliance with both local and international legal standards for pharmaceutical companies, CROs, and healthcare institutions. Possesses over 15 years of proven line management experience, demonstrating a strong ability to lead teams.
Accountable for oversight of service delivery for global studies involving Site Contracts services, including directing staff in Site Contracts Department and overseeing creation of global site contract language, budgets, payment schedules, and agreement templates with sponsors. Established contract and budget parameters, country-level process documents, and coordinated with internal and external stakeholders. Led teams of up to 40 personnel worldwide, supervising their performance and implementing training and improvement plans. Executed cross-functional team management for large-scale projects, ensuring timely and budget-compliant completion. Managed resource allocation, budget oversight, and compliance with agreed timelines. Additionally, interviewed, selected, and implemented onboarding and coaching processes for new department employees.
Provided strategic planning and oversight to support Site Contracts Team, ensuring activities aligned with contracted scope and executed within study timelines. Managed resourcing requirements of assigned studies and reviewed financial reports to track execution against proposed budget.
Conducted line management of Site Contracts team members and ensured contract templates and individual site contracts adhered to country regulatory requirements and procedures.
Oversaw day-to-day operations across Payments, Health, Life Insurance, and Medical Expenses Departments, ensuring efficient workflow and adherence to organizational standards. Delivered specialized support and guidance in development of Standard Operating Procedures (SOPs) for each department, enhancing operational consistency and compliance. Facilitated strong customer relations by addressing client needs and resolving issues promptly. Provided comprehensive line management to a team of 10 employees, encompassing training, performance improvement plans, career development, and overall performance evaluations. Achieved notable improvements in departmental efficiency and employee performance through strategic leadership and operational management.
Led creation and maintenance of Clinical Trial Agreements, Confidentiality Agreements, and negotiation guidelines for Latin America region. Supported development of training programs related to these agreements and guidelines, ensuring comprehensive understanding and adherence among staff. Provided specialized support and guidance to first-line negotiators on negotiation of Clinical Trial Agreements and Confidentiality Agreements. Acted as liaison with Janssen corporate legal for all legal matters pertaining to Clinical Trial Agreements in Latin America region, ensuring alignment with corporate legal standards and requirements.
Accountable for oversight of service delivery for global studies involving Site Contracts services, including directing staff in Site Contracts Department and overseeing creation of global site contract language, budgets, payment schedules, and agreement templates with sponsors. Established contract and budget parameters, country-level process documents, and coordinated with internal and external stakeholders. Led teams of up to 40 personnel worldwide, supervising their performance and implementing training and improvement plans. Executed cross-functional team management for large-scale projects, ensuring timely and budget-compliant completion. Managed resource allocation, budget oversight, and compliance with agreed timelines. Additionally, interviewed, selected, and implemented onboarding and coaching processes for new department employees.
Managed a team of Clinical Trial Agreements Specialists to ensure the smooth coordination of Clinical Study Sites and Investigator agreements across the Americas (Latin America, US, Canada) and Asia Pacific regions. Acted as the primary liaison with clinical sponsors on contractual language for Clinical Trial Agreements and Confidentiality Agreements. Facilitated communication with Covance's Headquarters Legal and Finance departments regarding agreement matters. Ensured adherence to sponsor contractual guidelines and maintained up-to-date knowledge of relevant legislation related to Clinical Research Trials
Responsible for drafting, reviewing and negotiating Clinical Trial Agreements with Clinical Study Sites and Principal Investigators for the following LA Countries: Mexico, Guatemala, Panama, Costa Rica, Dominican Republic, Puerto Rico, Chile, Colombia and Peru
Responsible of identifying and protecting company from unnecessary business and legal risk when taking decision for Clinical Trials Agreements with Clinical Study Sites and Investigators
Responsible of providing close contact with applicable company departments, Project and Upper Management teams
Meets with Sponsors as needed to plan and discuss action plans for Clinical Trial Agreements for each study; Modifies, implements and manages processes for execution of Clinical Trial Agreements according to each country local requirements.
Provided comprehensive day-to-day corporate legal advice to local industry, ensuring compliance and strategic alignment. Drafted, reviewed, finalized, and negotiated a variety of Civil and Mercantile Agreements, safeguarding company's interests. Delivered expert legal counsel on matters related to Industrial Property, Labor Law, Mercantile Law, and Civil Law, supporting informed decision-making and risk management.
Served as Paralegal, delivering comprehensive legal support across a range of activities. Drafted legal documents, filed motions and petitions, ensuring accuracy and compliance with legal standards. Conducted thorough analysis and preparation of contracts, safeguarding organization's interests. Provided valuable assistance in legal research projects, contributing to informed decision-making and strategic planning.
Management Skills: Project planning, task delegation, team communication and leadership
undefinedSpanish: Native Language
English: 95%