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.

Site Activation Lead is responsible for country study start up (SSU) activities and performing quality review of essential documents.  Site Activation Lead is responsible for overseeing and leading SSU activities in collaboration with country team members with the objective to improve site activation and maximize patient recruitment time.

Scope:

Site Activation Lead is responsible for the start-up of clinical trial activities in their assigned country/countries to achieve greenlight for selected sites. Site Activation Lead also performs quality review of essential documents at start up and during the lifecycle of the study, ensuring adherence to ICH-GCP guidelines, local requirements and sponsor’s QSDs. 

What you will be doing:

• Interact with site and study personnel to collect country specific documents such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. and review for accuracy, completeness and adherence to ICH/GCP and sponsors QSDs
• Perform quality review of country and site level essential documents following a risk-based approach, issue queries, and communicate outcome to identified users at key milestones and during the course of the study
• Prepare and submit regulatory and IRB/IEC documentation as required per country requirements and sponsor’s QSDs during the course of the study
• Preparation, tracking, and distribution of site start up documentation including Investigator Site File
• Obtain any required approvals for relevant site document (e.g. informed consent, financial disclosures) to ensure start up timelines are met
• Manage oversight, in collaboration with CLM, of country and site start up activities and eTMF quality using Vault Clinical reports and dashboards
• Support start up process improvement implementation
• In collaboration with CRA, maintain and ensure accuracy of site information in Vault
• Assist with audits/inspections of relevant start up activities and/or eTMF
• Attend and actively participate in team meetings by providing site greenlight projections and timelines
• Provide input on site activation strategy
• Ensure awareness of related local regulations and support maintenance of country intelligence in Veeva

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Qualifications:

• The incumbent should have a Bachelor’s degree (or equivalent experience) and minimum of 2 years of experience in clinical development including start up/ regulatory process experience
• Understanding of ICH-GCP essential documentation and familiarity with country specific clinical trial regulations
• CTIS knowledge
• Demonstrated ability to quality review documents and identify discrepancies/inconsistencies preferred
• Ability to embrace Veeva Clinical Vault system and associated functionality
• Strong written and verbal English communication skills
• Ability to work independently and manage multiple tasks and priorities

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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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. 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.