Site Activation Lead

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

The Site Activation Lead is responsible for defining, developing and delivering the global study start-up project strategy. He / she will be assigned to one or more interventional studies in one or more therapy areas such as oncology, vaccines, internal medicine, rare disease or inflammation and immunology. The responsibility typically ends when all investigative sites are activated and ready to enroll participants; however, this can extend further into the participant recruitment period to specifically deliver the implementation of protocol amendments across active sites for selected studies.

RESPONSIBILITIES

• Partner with country / site feasibility specialists to incorporate up-to-date intelligence for the planned countries and sites into the overall start-up strategy and site activation plan.
• Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start-up functions (e.g. site essential document collection, site contracts and budgets) to align country and site activities to form a robust start-up strategy and site activation plan.
• Accountable for quality and completeness of start-up timeline plans at study, country and site level.
• Co-ordinate across the study team and extended partners to deliver site activations to plan for the study or regions / countries assigned, assessing the ongoing site activation readiness status as well as proactively identifying and mitigating risks.
• In conjunction with study management roles, ensure consistent participant compensation for sites and institutions taking part in multiple studies concurrently to eliminate knock-on impact across studies.
• Lead start-up meetings that facilitate alignment of site selection to activation activities performed by country-level start-up roles with the endorsed trial optimization plan (by senior leadership).
• The Site Activation Lead will work with country-level start-up roles to seek opportunities to accelerate site activations for their study, considering the relative priority of their study compared to all concurrent studies in start-up that country-level start-up roles are working on.
• Act as a key point of escalations for site activation related issues raised by country-level start-up roles.
• Responsible for the completeness and quality of site activation timeline plans for every site from investigator initiation package sent for the first site in study to site activation complete for the last site in study.
• Understand the critical path activities for all sites based on specific needs of every site and their associated upstream country and study-related tasks.
• Plan and execute the timely delivery of the investigator initiation package needed for investigational product release to site in partnership with document owners (particular country-level roles), including incorporating the translation requirements into that plan.
• Work in lockstep with specialist roles that work directly with sites on the study budgets and contracts to bring this key activity off the site activation critical path.
• Co-ordinate across all roles that work directly with site staff to complete site activation readiness tasks (system access and training, protocol-related training) to time completion prior to the site initiation visit, or as soon as possible afterwards to reduce or eliminate from the site activation critical path.

Minimum Requirements :

• Extensive global start-up clinical trial / study management experience.
• Comprehensive working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations.
• A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology.
• BS / BA – 5 years relevant experience.
• MS / PhD – 3 years relevant experience.
• Fluency in English is required.

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.

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize 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 specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers website to read more about the benefits of working at ICON :

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.

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.