Clinical Trial Manager

As a Study Start-Up Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

We are proud to welcome you to join us on our mission to shape the future of clinical development.

We’re partnering with a leading global pharmaceutical company in Vilvoorde to find a skilled Study Start-Up Manager.

Whether you prefer working close to home or remotely, both options are open — our client supports flexible working arrangements to suit your lifestyle!

What you will be doing:

• Contract negotiations with sites
• Partners with Study Start-Up CRAs to drive all trial level start up activities 
• Leads country site initiation and patient enrolment plans
• Provides training to the local team
• Leads/chairs local Study Start-Up team meetings in assigned studies, participates in global study team meetings
• Oversees local SSU team activities in assigned studies to achieve start-up timelines and quality execution
• Ensures sites are prepared for “Green Light” and ensures all documentation is in place for initial and subsequent drug release.
• Responsible for review and sign off of the site “Green Light”
• Oversees local vendor selection and performance as needed. Serves as main contact for quality / compliance issues in SSU phase, escalating as necessary
• Implements innovative and efficient processes
• Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness
• Coordinates reportable events and notifications to IRB/IEC and Health Authorities as applicable
• Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders
• Prepares and finalizes local submission package for submission to IRB/IEC, CTA Hub (Europe: acc. to new EU-CTR) as well as Health Authorities as applicable 
• Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/IEC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA
  
  

You are:

• Experienced in the world of clinical trials with an extensive experience in study start-up
• Holding a background in Life Sciences (Bachelor or Master)
• An excellent negotiator, which will enable you to negotiate site contracts
• Having experience in overseeing and leading activties
• Motivated, Dynamic to start in a fast-pacing environment

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.