Dan has been in the industry for 25 years, with 16 years focused on medical devices. He has experience in a variety of therapeutic areas, including: wound care, orthopedics and reconstructive surgery. His expertise covers all aspects of clinical research, including study design, set-up and execution of global studies, from small first-in-human studies to large observational registry studies.

CORE COMPETENCIES

• Providing leadership, planning, coordination and oversight of the European Clinical Study Management Team
• Coaching and development of talent within the European Clinical Team
• Managing clinical research activities, including developing clinical study documentation, clinical trial conduct, data coordination, reporting and communicating results
• Ensuring clinical studies (Clinical Investigation and Post Market Clinical Follow-up) are conducted according to applicable regulations and procedures with a high ethical/quality of standards, allowing clinical trial documentation to be in audit-ready condition
• Overseeing clinical study execution to ensure studies are completed on time, within budget and in compliance with SOPs, ICH/GCP guidelines and applicable regulations

RECENT PROJECTS

• Guided clinical strategy, including global requirements for efficient project start-up
• Supported the successful completion of Clinical Investigation of an active implantable medical device in oncology
• Provide training and development to external parties on the design, set-up and execution of Clinical Investigations, both Pre and Post-Market within Europe