Project Manager FSA

Project Manager, FSA - India - Office or Home

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're currently seeking a Project Manager, FSA (Feasibility Site Activation) to join our diverse and dynamic team.
As a Project Manager within the FSA team at ICON, you'll be instrumental in driving the timely and efficient activation of clinical trial sites across global studies. Your leadership will ensure alignment with strategic objectives, regulatory compliance, and sponsor expectations — ultimately accelerating study start-up timelines and contributing to successful clinical trial execution.

What you'll be doing:

• Driving site activation: Leading and managing the successful activation of sites from identification to IP release across multiple countries and projects.
• Study start-up planning: Developing, implementing, and overseeing Study Start-Up Plans, including integration into the Project Management Plan and alignment with sponsor expectations.
• Stakeholder collaboration: Acting as the primary point of contact for sponsors and internal teams including Regulatory, Contracts, CTMs, and Site ID, ensuring transparency and alignment across functions.
• Regulatory & ethics submissions: Overseeing submissions to Regulatory Authorities, Ethics Committees (ECs), and other relevant bodies, ensuring timely and high-quality execution.
• ICF and document review: Managing the development, finalization, and review of Master and Country-Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs), as well as EU Clinical Trial Application forms (where applicable).
• Contract & budget management: Coordinating site contract and budget negotiations, tracking site activation costs, identifying out-of-scope activities, and supporting change order processes.
• Timeline management: Forecasting and tracking study timelines and deliverables, identifying potential roadblocks, and implementing proactive mitigation strategies.
• Team leadership: Leading cross-functional SSU teams across regions, mentoring junior staff, and contributing to team development and training initiatives.
• Reporting & communication: Preparing and delivering study metrics and regular updates to internal and external stakeholders, supporting client meetings and bid defenses.
• Quality & compliance: Ensuring compliance with ICON SOPs, ICH-GCP, and local regulatory requirements, with responsibility for documentation accuracy and audit readiness.

Your profile:

• Minimum 8 years of experience in Study Start-Up activities, including global project oversight.
• Strong knowledge of EUCTR, ICH/GCP, and global regulatory requirements for site activation.
• Experience managing budgets, contracts, and timelines across multiple global studies.
• Excellent leadership, communication, and organizational skills with a proven ability to work cross-functionally.
• Hands-on experience coordinating with global and regional teams to ensure on-time site initiation.
• Previous client-facing experience including Bid Defense and Kick-Off Meetings is preferred.
• Ability to manage competing priorities and maintain attention to detail in a fast-paced environment.
   

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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.

Are you a current ICON Employee? Please click here to apply