Study Start-Up Lead

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

What you will be doing:

• Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA)
• Executes and oversees clinical trial country submissions and approvals for assigned protocols.
• Provide support and oversight to local vendors.
• Oversees FCPA, DPS/OFAC, and maintenance of financial systems
• Works in partnership internally with 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 related- interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.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
• Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTAs and local milestones.
• Collaborates closely with Headquarter to align country timelines for assigned protocols.
• Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
• Ownership of local regulatory and financial compliance.
• Required to in/directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.
• Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as  appropriate/required.

Requirements

• University degree
• 5-7 years of experience in clinical research or combined experience in Clinical Research
• Previous experience in budget and contract negotiations or/and local regulatory environment and submission and approval processes, and understanding of how these impact study start-up is required
• 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
• Required strong understanding of local regulatory environment in Romania
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, 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.

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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