Michał Czernichowski - Stanek

CTM: Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the Customer. Manages all clinical aspects of allocated studies. Serves as the primary Clinical Management contact for the Project Manager.

Responsible for the co-ordination and management of all Clinical Management project team members on an international basis (particularly CRA’s), within designated projects. Implements and manages the necessary training, tracking and quality systems within the clinical portion of the project. Involved in regular and proactive liaison with the Project Manager, Clinical Managers and other functional groups as appropriate.

Co-ordinates standardised start up and clinical monitoring guidelines (in conjunction with query guidelines). Ensures essential document quality. Reviews monitoring visit reports. Performs co-monitoring visits where necessary. Identifies and performs any required troubleshooting activities. Manages query resolution process.

Site Intelligence and Activation – Team Manager (Secondment). Leads and manages site start-up
portion of assigned project. Directs the technical and operational aspects of site start up deliverables across
countries. Works with major functional area leads (project management, clinical management, legal and
regulatory) to identify, evaluate, coordinate and oversee fundamental issues pertaining to the successful site
start-up of the project. Provides accurate projections, reports, updates and ongoing risk assessments.
Accountable for achieving the final SIA deliverable (usually projected site activations) within the time period
specified in the contract with the Customer. Manages all