strategic and operational leadership of clinical studies and management of Clinical Operations professionals for implementation and the execution of clinical trials.

Global management of phase 3 pivotal studies in episodic and chronic migraine from setup to successful closure through FDA and EMA marketing approval.

Personnel ManagementResource ManagementQuality Control/Technical Support Operations Management

Responsibilities include managing clinical monitoring activities and liaising with project management and the sponsor to ensure that the clinical deliverables are met. Responsibility enclosing all financial aspects of the study, Co-ordinates the clinical team and supports the Project Manager, working closely with Finance, Medical and Regulatory Departments, Account Directors, Contract Managers, other functional leads and the sponsor.

Clinical trials monitoring in accordance with the ICH Guidelines, the current monitor guidelines and SOP’ s including identifying sites, preparing documentation for necessary approvals, initiating sites and observing recruitment, performing monitoring at sites, reporting visits and contacts with site, assuring the presence of all relevant documents on site, collaborating with other departments for reporting safety information, collecting Case Report Forms, following up and solving data queries, reporting the progress of the study on a regular basis and performing site close-out visits. Functioning as mentor and role model for other CRA team members, performing co-monitoring visits with less experienced CRA’s or at problem sites, as required.

Responsibilities include pre clinical trials monitoring, preparing documentation for necessary approvals, performing monitoring visits and assuring the presence of all relevant documents on site.