Clinical Trial Manager

As a Clinical Trial 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, Sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Under the oversight of Senior Clinical Trial Manager the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure site readiness.

Responsibilities include, but are not limited to:

• 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. Financial forecasting
• Develops local language materials including local language Informed Consents and translations. Interacts with Ethics Committee 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. 
• Coordinates and liaises with study team (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. 
• Provides support and oversight to local vendors as applicable.
• 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. 
• Ownership of local regulatory and financial compliance. 
• Required to in/directly influence investigators, external partners and country operations to adhere to partners and country operations to adhere to budget targets and agreed payment timelines.

• 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business
• Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience
  
• Experience in Submission Specialist role, with knowledge/experience of contract and budget negotiation

Why you are a good fit for this role:

• You are a strong communicator, have strong leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in Dutch and English.
• You are problem-solver, independant worker and like the dynamics of start-up!

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.

#LI-Hybrid

#LI-VV1