Study Start-up Associate II

ICON Strategic Solutions; Town of Belgium (WI); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Competitive retirement planning

LifeWorks EAP program

Life assurance

Country-specific benefits

Job summary

ICON plc is a world-leading healthcare intelligence and clinical research organization seeking a Study Start Up Associate II to lead initiation of clinical trials, ensuring regulatory compliance and advancing innovative therapies.

You will manage site start-up activities, collaborate with internal teams, CROs, and TAU partners, and ensure timely site activation while maintaining high quality eTMF records.

Qualifications

• BS degree or international equivalent.
• 2+ years of experience in clinical research Site Start Up within pharma, CRO or vendor.
• Ability to explain data to facilitate data-driven decision making.
• Knowledge of clinical study protocols and essential documents.
• Strong organizational, decision making, communication and negotiation skills.
• Proficient in Microsoft Excel, Word, and PowerPoint.

Responsibilities

• Work with sites on site-related essential document collection and review.
• Collaborate with internal Study Startup team, CROs, Clinical Operations, and TAU partners to improve SSU metrics.
• Ensure standards are applied to SSU processes across projects.
• Review site essential documents for start up (ICF, FDF, 1572, CVs, etc).
• Identify and escalate start-up delays to the appropriate team members.
• Track actions and communications with sites to meet study/timelines.
• Assist in resolving escalated issues identified by CROs and Clinical Operations.
• Review and provide feedback on site performance metrics.
• Ensure accuracy and completeness of the eTMF for assigned sites.

Skills

Organizational skills

Communication

Negotiation

Decision making

Microsoft Excel

Microsoft Word

PowerPoint

Data-driven decisions

Education

BS degree or international equivalent

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Job description

SSU I Study Start-Up

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

What You Will Do

You will contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively.

Key Responsibilities Include

• Work directly with assigned sites on all site related essential document collection and review.
• Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics and deliver processes.
• Ensure standards are applied to the SSU processes across projects.
• Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etc
• Promptly recognize and improve potential site activation delays and elevate to appropriate team members.
• Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
• Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
• Review and provide feedback to management on site performance metrics.
• Ensure accuracy and completeness of the eTMF for assigned sites during start up

Your Profile

You will bring relevant site start-up and activation experience, along with the following qualifications and skills.

Required Qualifications And Experience

• BS degree or international equivalent
• 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.
• Ability to explain data to facilitate decision making processes to be data driven.
• Knowledge and understanding of clinical study protocols and essential documents
• Strong organizational skills, decision making, communication and negotiation skills
• Proficient in Microsoft Excel, Word, and PowerPoint.

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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, 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 site to read more about the benefits ICON offers.

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.

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 or submit a request here

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.