CTM

For our client, a global biotech pioneer, located in Diegem (Belgium), we are looking for a Local Trial Manager to join our growing group of ICON representatives.

With a presence within approximately 100 countries and regions worldwide our client has reached with their innovative medicines millions of people in the fight against serious illnesses.

In this position you will be the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a
country level

In terms of actuals tasks, this means you will have the following responsibilities:

• 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.
• Planning, management, and oversight of clinical study execution
• 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 the study team meetings
• Communicate country status (including timelines and deliverables) to key stakeholders
• Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country(ies)
• Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training
• Oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning
• Monitor country enrolment and retention and act on deviations from plan.
• Review Monitoring Visit Reports
• Identify and facilitate resolution of cross-functional study-specific issues
• Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range)
• Escalate any issues related to delivery, timelines, or budget to GCMs.

To be succesfull in your role, we are looking for most of all enthusiastic colleagues, willing to shape the future with us.
Furthermore we consider that following qualifications/experience will be an advantage to find the best match:

• Higher degree in life sciences or equivalent by experience
• Advanced knowledge of global mimimum 2-3 years’ experience of leading local/regional or global teams
• Minimum 2-3 years’ clinical trial project management experience
• 7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience
• Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
• Fluently in Dutch and English

Why ICON?

Some of our advantages in short:

• Comprehensive and competitive total reward package (group insurance, hospitalisation, ECO-voucher, Lunch vouchers, Homebased allowance,...)
• we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
• Dedicated line manager as of the first day!
• Homebased contract

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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