Site Activation Lead

The Site Activation Specialist is responsible for site start-up activities for the assigned studies within the Site Alliance and Site Activation Sub-Chapter under Clinical Operations. The position will require strong stakeholder management working closely with Contracting, Legal, Privacy, Study Teams, CRO, and Sites.

What you will be doing:

● Responsible for the effective operations and delivery of site activation deliverables across all regions, within the assigned projects.

● Supports the pre-study site identification/selection process for relevant studies through collection and analysis of site feasibility information.

● Maintain regular communications with investigational sites/CRO to ensure timely completion of the required site activation activities/documentation and resolve or escalate issues in a timely manner

● Collect, receive and perform the first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines, and study timelines and requirements

● Coordinate Investigator Review Board (IRB)/Ethics Committee (EC)/other relevant regulatory submissions in collaboration with sites/study teams

● Work with sites to ensure informed consent form meets the required regulatory and company requirements.

● Facilitate the translation of essential documents that may be required in languages other than English for the purposes of submission to and approval from Competent Authorities and/or IRB/EC.

● Coordinate the clinical trial insurance process to ensure timely results and support throughout the conduct of the clinical study.

● Support contract and budget negotiations in partnership with Contracting and Study Teams.

● Ensure Purchase orders and Fair Market Value assessments are completed for timely start-start up.

● Support study instrument placements, Obtain import/export licensure

● Support implementation and use of eTools at the site

● Collect and maintain relevant country, local, state, and site-level regulatory intelligence for future use

● Work closely with Study Teams to deliver study start-up tasks.

● Solve identified issues with appropriate timely escalation to the Study Teams

● Support internal audit and external inspection activities; contribute to CAPAs as required.

● May be responsible for other responsibilities as assigned.

You are:

● Associate or Bachelor’s degree in chemistry, biology, other life sciences, or a related field, or equivalent combination of education and experience
● Experience in study start-up is required
● Experience with CRO management is a plus.
● Experience in clinical trial planning, including IRB/Ethics Committee, Competent authority submissions and contracts
● Knowledge of clinical trial methodologies, medical terminology, ICH/GCP
● Must be fluent in English, and the language of the appointed location
● Working knowledge of global and local regulatory requirements (IVDR and other applicable regulations) is a plus.
● Understand the quality expectations and emphasis on the right first time, attention to detail
● Ability to organize tasks, time, and priorities, ability to multi-task
● Required to support multi-national team members, and flexibility in working hours may be needed.
● Participate and work effectively with multiple cross-functional teams

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.