Fred Kaczmarek

Background

About Fred Kaczmarek

Greetings, thank you for locating me on LinkedIn. Work bio: Fred Kaczmarek has 20+ years of total clinical research experience in drug/device trials across contract, biotech, and pharmaceutical research organizations. For the past 12 years, Fred managed and directed clinical research operations and initiatives for teams including managers in the US. He provides an exemplary work ethic, ensuring project success through leadership and adept managerial support. Mr. Kaczmarek’s responsibilities include effective liaising with KOLs, customers and third party partners, as well as the efficient coordination and management of the following matrix environment: Clinical Operational management, Monitoring/Site Management, Data Management, Regulatory Affairs, Medical Monitoring, Pharmacovigilance Surveillance & Reporting, and Quality Management. As a leader, Fred is recognized as an accomplished communicator, problem solver and project specialist. He provides exceptional planning, organization, and relationship management skill. He is experienced in building and maintaining collaborative teams/relationships, provides strong mentoring and is considered an expert in operations. Specialties: Strategic Leader, Global Management of CRAs and CRA Managers, Risk and Remote Based Monitoring, Clinical Research Organizations, Inspection Readiness Monitoring, Quality Control and Management, Problem Solving, Employee Management, Planning of Operations, Training, Change Management & Integration. Therapeutic Experience: Cardiovascular (6 years), GI (2 years), Endocrinology (18 years), Dermatology/Aesthetics (3years), Device (2 years), Hemostasis (4 years), Kinesiology (4 years), Oncology (3 years), Ophthalmology (3 years), CNS (5 years), Pulmonology (3 years), and Phase-I management and oversight specific (5 years)