Clinical Study Start-Up Lead

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

We are looking to recruit experience SSU Lead to join our FSP team at ICON Romania. In this role you will be responsible for budget/finance aspects, for execution and oversight of EE CTR submissions, site contract negotiations in Romania.

Responsibilities:

• Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
• Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out.
• Executes and oversees clinical trial country submissions and approvals for assigned protocols.
• Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
• Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
• Provides support and oversight to local vendors as applicable.
• Required to in/directly influence investigators, external partners and country operations to adheres to budget targets and agreed payment timelines.
• Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory
• Authorities in submission and approval relatedinteractions.
• Contribute or lead initiatives and projects adding value to the business
• Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required

Requirements:

• Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related
  experience
• 5-7 years of experience in clinical research or combined experience in Clinical Research and Finance/Business
• Experience with site budget and contract negotiations, local regulatory environment and EU CTR submission and approval processes, and understanding of how these impact study start-up
• Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the SCOM or manager.
• Ability to make decisions independently with limited oversight from SCOM or manager.
• Requires strong understanding of local regulatory environment
• Ability to lead a team

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.

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