Study Start Up Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. The Study Start Up Manager is accountable for study planning, Study Start Up activities and activation deliverables of assigned projects. Responsible for GCP/ICH and regulatory requirements in a stand alone country. The SSU managaer will lead all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global Study team. 

What you will be doing:

• Support country SSU strategy in close collaboration with SSO Study Start-Up team lead
• Accountable for timely start-up activities from country allocation until green light
• Ensures Study stat-up activities are conducted on time
• Prepares and finalizes local submission package for submission to IRB/IEC, CTA Hub as well as Health Authorities as applicable (including subsequesnt amendments, IBs, DSURs, CSRs)
• Accountable for timelines, accuracy and quality of country TMF documents in study start up to ensure TMF inspection readiness

You are:

• Must be based in the Netherlands
• Must have Start-Up experience
• Minimum 5 years experience in clinical project/trial manager role that oversees monitoring clinical trials
• Capable of leading in a matrix enviroment

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/benefitsICON, 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 or submit a request here.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.