Study Start Up Associate II

About the role

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

Responsibilities

• 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.
• Promptly recognize and improve potential site activation delays and escalate 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.

Requirements

• 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.

Benefits

• 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.