CTM

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

We are looking for a Clinical Trial Manager based in the Netherlands

 Key Purpose:

• Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up (COLA) to close out at a country level in accordance with ICH-GCP and other applicable local regulations
• Maintain the quality and scientific integrity of clinical trials at a country level.
• Collaborate with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial.
• Maintain expert country, site and protocol knowledge to support sites with questions as well as build strong site relationships.
• Partner with global, local country teams and study team to provide high level country strategy, drive study progress and country level study delivery. (Accountable for study deliverables and drives key decisions within set country) Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST)
•  Supports country-level operational planning and accountable for site selection within assigned country(ies)
•  Contribute and develop to program,/study-specific materials – e.g., monitoring plan, study specific training documents.
•  Support and contribute to Clinical Study Teams (CSTs) / Trial Management Teams(TMTs) as applicable, agenda driven, present at meetings.  Communicate country status (including timelines and deliverables) to key stakeholders (e.g., GCMs, Program Managers, CST or TMT, DOM etc) with oversight as     required and ensures updates to relevant systems

• Basic Qualifications:
• Ÿ     Doctorate degree OR
• Ÿ     Master’s degree 3 years of directly related experience OR
• Ÿ     Bachelor’s degree & 5 years of directly related experience OR
• Ÿ     Associate’s degree & 10 years of directly related experience OR
• Ÿ     High school diploma / GED & 12 years of directly related experience
• Ÿ     Advanced knowledge of global clinical trial management
•  
• Preferred Qualifications:
• Ÿ     BA/BS/BSc
• Ÿ     Minimum 2-3 years’ experience of leading local/regional or global teams
• Ÿ     Minimum 2-3 years’ clinical trial project management experience
• Ÿ     7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company