Koen de Backer

Background

About Koen de Backer

16+ years of Clinical Research experience - Mentoring and coaching of new colleagues - Review of SOPs, work procedures and guidelines - Member of several Process Improvement work groups - Develop tools and systems for patient recruitment tracking and forecast - Develop, monitor and maintain the clinical budgets - Interact with Key Opinion Leaders to develop novel study designs and decide on relevant endpoints - Lead and motivate cross-functional, multi-cultural project teams - Manage large pivotal studies with very high pressure on timelines and other Phase II, IV and expanded access studies - Manage Contract Research Organisations and other vendors - World-wide experience (EU, US, Latin America, South Africa, Asia, Australia, New Zealand)- Experience with HIV, Hepatitis C, gastro-enterology, Parkinson’s Disease, influenza vaccines and ovarian cancer - Write protocols and informed consents - Develop user requirement specifications for central lab, IVRS/IWRS, eCRF, central ECG, e-diaries- Create guidelines and project plans - Review investigator agreements - Oversee Health Authority and Ethics Committee submissions - Present at Ethics Committee meetings - Present at patient advocacy group meetings - Organize and present at Investigator Meetings - Follow up on subject recruitment targets and initiate recruitment actions where needed - Control study budgets and timelines - Supervise database lock and clinical study report review - Clinical Operations expert with strong scientific background - Strong interest in improving performance by increasing efficiency - Excellent sense for managing operational & clinical challenges - Pro-active thinker - Analytical problem solver - Motivating team leader with good coaching and mentoring skills - Multilingual - Flexible and quick learning