Project Specialist

ICON Clinical Research; City of Rome (NY); Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement plan

Life assurance

Employee assistance program

Flexible benefits

Job summary

ICON Strategic Solutions is recruiting for a Project Specialist / Study Delivery Specialist to support global study management in a sponsor-dedicated model. The role is remote and involves collaboration with PMs across EMEA, APAC, and the US, ensuring high-quality study delivery and data integrity.

The ideal candidate has 1–2 years in clinical trials, experience with eTMF/CTMS, and strong English plus MS Office skills.

Qualifications

• University degree required.
• 1–2 years of clinical trial experience.
• Available to start within 1–2 months.
• Experience with eTMF and CTMS is a plus.
• Fluent English and strong MS Office skills.
• Excellent stakeholder management and communication.

Responsibilities

• Support global study management with PMs across regions (EMEA, APAC, US).
• Oversee budgets, change orders, and expenses; track updates.
• Serve as the primary contact for vendors and internal partners.
• Review key clinical documents and help develop study plans (e.g. Monitoring Plan, Risk Plan).
• Monitor study progress, identify risks, and escalate issues.
• Maintain study data systems, access permissions, and data integrity.

Skills

Clinical trial experience

eTMF

CTMS

Advanced Excel

Budget tracking

MS Office

Stakeholder management

Fluent English

Education

University degree

Tools

CTMS

eTMF

Job description

Project Specialist / Study Delivery Specialist / SMA / Project Coordinator - Remote

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

We are seeking candidates interested in a global study management role, where they will support global project managers across EMEA, APAC, and the US.

In this position, you will work remotely as an integral member of the sponsor’s global study team.

Responsibilities & Tasks:

• In this role you will be a key member of the sponsor's Global Study Management Team

• 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 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

• You will be acting as a primary point of contact for vendors, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties.

• Oversight of eTMF completeness

• 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:

• University degree

• 1 -2 years of clinical trial experience within clinical research

• Availability to start within 1 - 2 months max

• Experience in global 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:

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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations)