Senior Study Site Specialist

Under the guidance of the Director of Global Site Management & Central Services, this position will be responsible for conducting end-to-end site management from feasibility to site activation serving as the primary point of contact for the site and the study team. This includes supporting site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification, and all study and site start-up, maintenance and close-out activities.

• Assist in development of in-house model process documents.
• Serve as an In-House Study Lead, a primary point of contact to study team on end-to-end study activity.
• Lead In-House Study team meetings as appropriate.
• Participate in In-House Study Management meetings.
• Utilize tools to track activities and develop reports.
• Oversee Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Feasibility Questionnaires.
• Oversee site contract/budget negotiations (Confidentiality Agreements, Clinical Trial Agreements and Ancillary Agreements).
• Oversee essential document collection, tracking & review.
• Support the collection of country and site level intelligence.
• Support Ethics Committee and Regulatory Authority submissions.
• Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a study as appropriate.
• Assist in the development of In-House study processes and procedures.

• Bachelor’s Degree in Business Administration, Finance, science or related field.
• Minimum of five years of relevant experience in the biopharmaceutical/CRO industry.
• Global experience in the US and EU.
• Flexibility to assume a workload, which frequently necessitates an adjustment of priorities.
• Goal oriented, self-starter with proven ability to work independently.
• Able to proactively identify issues and provide potential solutions for resolution.
• Detail oriented.
• Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
• Proficiency with Veeva Vault and all applications of Microsoft Office.
• Good interpersonal skills.
• Comfort with ambiguity; ability to act without having the total picture.

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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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.