Warsaw, Mazowieckie, Poland
I have extensive experience in creating regional and country templates for clinical trials, negotiating agreements and study budgets. Currently, as a Regional Contract Manager, I am fully dedicated to resolving legal problems related to the clinical trial agreements, ancillary services agreements and confidentiality agreements in EMEA region. I gained my experience working at CROs companies as well as directly for sponsors.
Managing the entire Clinical Site Agreement (CSA) process for a number projects, including the development of the study specific CSA strategy with the Sponsor, preparation of the corresponding country specific CSA templates and country specific budgets and also negotiation of such CSAs and budgets with the individual sites located in Europe region.
• Negotiation and finalization of clinical trial agreements, clinical services agreements, confidential disclosure agreements at a legal and financial level; • Performing and coordination of study start-up activities (country and site feasibility, contract negotiations, creating submission strategies to EC and RA, SIV planning; • Cooperation with CRO partners – daily issues solving, exchange of experience, building start-up strategy for current projects (studies); • Legal support; • Building relationships with sites and principal investigators.
• Negotiation and finalization of clinical trial agreements, clinical services agreements, confidential disclosure agreements at a legal and financial level; • Amending above mentioned agreements; • Calculating clinical trials budgets; • Ambassador of the local team on international Amgen forum; • Current support of company in clinical trial issues.