Dirk Strickmann

Founder, heading project management,, monitoring and drug safety; Responsibility for the financial management of the company including budget planning and resource allocation; Coordinate the smooth monitoring of all trials by identifying and managing qualified staff, establishing audit procedures; Implement training programs for CRAs and other clinical staff; Supervises CRAs in in-house and on-site monitoring, filing, and trial administration; Oversees adherence to SOPs, GCP and current regulations

Lead project team in designing development strategy for a clinical trial, optimizing risk, cost, quality, and time tradeoffs consistent with sponsors objectives; Monitor progress of development project, ensuring that key requirements and milestones are identified and met; Develop clinical team, based upon expertise and knowledge; Oversee project operations with Data Management, Biostatistician, Quality Assurance, Reg Affairs, Drug Safety, Medical Writers and Clinical Operations

Experience in clinical trials management; Coordinated and managed clinical monitoring of multinational studies according to ICH/GCP Guidelines; Coordinated CRAs; Mentoring of CRAs on monitoring and internal procedures; Liaison with clients (sponsors, investigators, hospital depts. and labs); Negotiate study budgets and contracts with investigational sites; Met administrative requirements (correspondence with ECs, the German health authorities and provincial authorities)

Monitored in accordance with ICH/GCP Guidelines and the current monitor guidelines and SOPs; Performed monitoring visits at sites, reporting visits and contacts with site, assuring the presence of all relevant documents on site Collaborated with other departments; Created data queries, following up and solving data queries, reported collected data by entering the information into a study database; Identified sites, prepared documentation for approvals and collected essential study documentation