Site Management Associate I

Site Management Associate

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

We are looking for candidates to work in a role in study management supporting global project managers in EMEA, APAC and US.

In our role you will work remotely and be part of the sponsor's global study team. 

What You Will Be Doing:

• In this role you will be a key member of the sponsor's Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness

• Responsible for budget oversight – managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the Project Manager

• You will be responsible for country oversight, acting as a primary point of contact, tracking of recruitment progress, data completeness and compliance, overseeing local budgets, protocol deviations, risks, regulatory approvals and import license status

• Vendor management and CRO oversight, acting as a primary point of contact, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties. 

• Data oversight, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination), and assure that all eTMF documents are complete and verified for quality.

• Maintaining interactions and meetings with internal and external partners

• Responsible for reviewing key clinical documents, including the Protocol and Informed Consent Forms, and leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan etc.) for external and internal use in assigned studies.

• Monitoring study conduct and progress, identifying, resolving and escalating risks/issues 

• You will be responsible for setting up and maintaining systems and tracking tools that ensure quality, consistency and integration of study data, following up on discrepancies if needed. Granting access to new system users.

Your Profile:

• PharmD Degree is required / Life Science degree

• 1+ years of clinical trial experience within clinical research

• Must have Experience in global Study delivery /project management/supporting global cross-functional teams at study level would be an advantage

• Experience working with eTMF and CTMS

• Fluent English

• Very good comprehension of Microsoft Office tools (Excel, PowerPoint, Word, Outlook, etc.).

• Knowledge of advanced Excel, timelines/budget tracking systems and clinical trial management systems is an asset.

• Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills.

What ICON can offer you:

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.

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