Christopher Kowalczyk

WORK HISTORY

EDUCATION

ABOUT CHRISTOPHER KOWALCZYK

My background as a clinical monitoring professional with extensive experience in Risk Management, Gap analysis, business analysis, complex data analysis, managing key performance indicators (KPI), and quality metrics to support excellence in clinical trials. Excelled in design and implementation of Clinical Trial Management Systems, implementation of study specific monitoring visit report templates. Advanced execution of site protocol training and compliance queries, draft protocol queries, case report confirmation and follow-up letter uploads, and on-line/off-line monitoring trip report builds. As an architect I am highly experienced in the design, implementation, and entry of long-term strategies to meet data management and storage needs of the department. Lead internal team to conduct validation checks of training documentation on key studies under FDA watches using data visualization and modeling structure simulations. Develop long-term strategies to meet data management, storage, and dissemination requirements to meet departmental, company, and client needs, as well as adhering to company specific SOP’s, and FDA guidelines. I Possess diversified skills to direct and coordinate small to large project activities using Gap analysis, agile approach, and traditional waterfall methodology. Through active communication, worked on multiple projects in several stages concurrently to ensure they fell within the scope, phase, and cost of the required study parameters. Highly skilled in Gap analysis, quality process, metrics establishments/reports, and data analysis; to determine deficiencies in process requirements vs. quality of work performed in order to provide a corrective and mitigating action plan.