Manager, Study Start Up

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

Responsibilities:

• Supports country SSU strategy in Bulgaria & Romania in close collaboration with Study Start-Up Team Lead and Country Head
• Collaborates with local and global study team to ensure SSU timelines and deliverables are met according to country commitments
• 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 Sponsor 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
• Accountable for timely start-up activities from country allocation until 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
• Oversees and manages  the preparation of 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
• 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
• Oversees local vendor selection and performance as needed.
• Serves as main contact for quality/compliance issues in SSU phase, escalating as necessary

Requirements:

• Minimum 5 years’ experience in start up (including EU CTR submissions), including 2 years as SSU Manager or SSU Lead (on the international level; experience in Bulgaria& Romania is an asset).
• 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

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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 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.

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