Microsoft Office, CTMS, Oracle, ERP, Activate
Experienced Contracts Specialist with a demonstrated history of working in the pharmaceuticals industry. Skilled in Microsoft Office, time management, negotiation, leadership, and project management. Strong analytical skills, legal professional with a Bachelor's Degree focused in Law. Fluent English speaker with global experience.
Strong experience negotiating clinical trial agreements and budgets for several therapeutic areas
(Oncology, Neurology, Ophthalmology, Cardiology, Respiratory) phases I, II, III & IV
In addition, I gained +2 years’ of experience negotiating service agreements / fixed rates with forwarders and some additional with customs brokers, while I was an import Supervisor for Grupo Bimbo (known as Canada bread bakery / Bimbo bakeries USA)
Dispatch, negotiation, execution and tracking site contracts, and related, i.e. FUA, LOIs, Hospital Letters
• Protocol reading / Comprehension
• Creation of master contracts and budgets templates for new-awarded studies.
• Lead start-up processes with multiple team members.
• Mentoring entry level Study Start-up Associates.
• Perform regulatory document maintenance, i.e. amendments, notice letters,budget modification letters.
• Prepare, submit and review QC submissions for final CTAs
• Collaborate with study managers and clinical operations leads to successfully meet Sponsor timelines goals and expectations.
• Organized and led study wide amendments.
• Attend weekly team meetings, daily reporting, tracking, and self-management.
As Supervisor on GB, I was in charge of the logistic and negotiation with forwarders, customs, compliance with local and international laws, internal records administration, payment management to international suppliers. Also worked during certain time on this company for the accounts payable department, learning how to manage some
ERP´s systems and the process from beginning to end of a payable invoice for the company.
Active Listening
Microsoft Office, CTMS, Oracle, ERP, Activate
Music, Gym, Family, Learning