Clinical Trial Manager

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

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, internal policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Under the oversight of the Senior Manager or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

What you will be doing:

• 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. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with Senior Manager /other roles.
• 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.
• Contributes to the development of local SOPs. Oversees CTAs as applicable.
• Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Headquarter to align country timelines for assigned protocols.
• Provides support and oversight to local vendors as applicable.

You are:

• 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business
• Expertise of core clinical systems, tools and metrics
• Excellent English skills
• Strong coordination and organizational skills
• Skilled knowledge of budget and contract negotiations, local regulatory environment and 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 manager.
• Requires strong understanding of local regulatory environment
• 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.