Job Description

OverviewAs a Site Activation Lead, you will be joining the worldxe2x80x99s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.ResponsibilitiesSite 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-ordinates across the study team and extended partners to deliver site activations to plan for the study or regions/countries assigned, assesses the ongoing site activation readiness status as well as proactively identifying and mitigating risks.
• In conjunction with study management roles is responsible for ensuring 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, they will do so while 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 first site in study, to site activation complete for last site in study.
• Understanding 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 lock step 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

Qualifications

• 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 xe2x80x93 5 years relevant experience
• MS/PhD xe2x80x93 3 years relevant experience
• Fluency in English is required

What ICON can offer you:Our success depends on the quality of our people. Thatxe2x80x99s why wexe2x80x99ve 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 familyxe2x80x99s 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 familyxe2x80x99s 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/benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. Wexe2x80x99re 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-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless xe2x80x93 therexe2x80x99s every chance youxe2x80x99re exactly what wexe2x80x99re looking for here at ICON whether it is for this or other roles.

ICON