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, SSU activities and activation deliverables of assigned projects in compliance with client processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team. In satellite countries acts as primary back-up and deputy of the country manager.
What you will be doing:
Supports country SSU strategy in close collaboration with Study Start-Up Team Lead, Country Head Portfolio / Cluster Head Portfolio
Collaborates with Country / Cluster Head Portfolio, Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments
Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects
Ensures close collaboration with local IRBs/IECs and 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 Hub for Health Authorities submissions, as required
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 (including subsequent amendments, IBs, DSURs, CSRs)
Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders
Coordinates reportable events and notifications to IRB/IEC and Health Authorities as applicable
Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness
Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
Implements innovative and efficient processes which are in line with client strategy
Supports study feasibility in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team.
Leads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assigned
In satellite countries oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues in SSU phase, escalating as necessary
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 SSU team activities in assigned studies to achieve start-up timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to client standards and local and international regulations
Leads/chairs local SSU team meetings in assigned studies, participates in global study team meetings, as required
Leads the development of country site initiation and patient enrolment plans together with SSU CRA, CPM and SSU Lead
Your profile:
Minimum 5 years’ experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
Capable of leading in a matrix environment, without direct reports
Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and client standards
Strong interpersonal, negotiation and conflict resolution skills
Communicates effectively in a local/global matrixed 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 maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
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 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.
Are you a current ICON Employee? Please click here to apply
