Koen De Backer Email & Phone Number

- 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, III, 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

Listed skills include Clinical Trials, Clinical Development, Cro, Drug Development, and 11 others.

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  Ku Leuven

  Msc