Study Start-up Manager (US - client dedicated)

Study Start-Up Manager (Client Dedicated - US)

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.

What You Will Be Doing :

• Manage and may lead the day-to-day operations within Study Start Up to ensure completion per established goals and objectives in compliance with applicable GCP / ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g. study teams) to support timely completion of both drug and non-drug program goals and objectives.
• Manage and may lead functional and cross-functional internal teams.
• Provide accurate and up-to-date project status and financial information within relevant tracking systems / tools.
• Proactively identify and escalate issues that arise related to support functional deliverables.
• Responsible for implementation of standards for designated functional areas.
• Provide oversight and direction to team members for functional and study-related deliverables.
• Accountable for functional budgets and resources and responsible for the management of related components of trial or support function budgets, timelines and resources. May also provide oversight for these activities.
• Responsible and may be accountable for all activities associated with Study Start Up. This may include : Oversight of SSU activities from receipt of a potential site list to site activation including CDA and questionnaire collection, site selection, IRB / EC submissions, IMP Release and other site activation requirements.
• Facilitating the development of the SSU Strategy and ensuring management of the strategy during the study start up period.
• Building relationships with key study team counterparts to support successful site activation strategies and ensure appropriate delegation of tasks during SSU.
• Driving site activation timelines to ensure timely completion and assist with mitigations and escalations to ensure milestones remain on track.
• Contributing to process and tool development to the support of the SSU team with day-to-day activities.
• Leading the preparation of study level essential document templates.
• Aiding in the preparation of content for Regulatory submissions.
• Supporting ICF negotiations and escalation.
• Review and Approval of IMP Release Packages.

Your Profile :

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 :

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, color, 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.

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.