Ángel M B.

Developed strong site relationships and ensured continuity of site relationships through all phases of the trial. Performed clinical studies site monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Performed remote and on-site monitoring & oversight activities using various tools to ensure that data generated at site was complete, accurate and unbiased. Conducted site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. Identified, assessed and resolved site performance, quality or compliance problems and escalated as appropriate in collaboration with CRA Manager as needed.

In charge of obtaining clients, negotiating contracts, representing clients at meetings, presentations at board meetings. Led the medical devices practice, with specialization on orthopedic surgical implants distribution entities, general businesses and cryptocurrencies. Obtained tax decrees with local authorities and provided full legal services.

Design and administrate protocols, SOP, trainings and strategies for compliance with regulations of the local and federal department of agriculture. Review and keep up to date with changes, and manage audits.

Graduated Cum Laude, Received the Legal Society Award for the most outstanding performance at Trial Courts.