(Sr) Project Manager, Feasibility Site Activation in Chennai, भारत

Project Manager FSA - India

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

At ICON plc , we are committed to improving and saving lives through clinical research. As a Project Manager – Feasibility & Site Activation , you will play a critical role in driving the successful start-up of global clinical studies.

This is a highly visible position where you will take ownership of the Study Start-Up (SSU) strategy and execution—ensuring that sites are activated efficiently, regulatory pathways are navigated effectively, and studies are positioned for successful delivery from day one.

You will work at the center of cross-functional collaboration, partnering with sponsors, internal teams, and sites worldwide to deliver start-up excellence at scale.

What You Will Be Doing

• Shape and execute Study Start-Up strategies across global, multi-country studies, ensuring alignment with timelines, scope, and sponsor expectations

• Lead the development and delivery of comprehensive Study Start-Up Plans, covering regulatory, ethics, and contract execution across all participating countries

• Drive end-to-end start-up activities from site identification through to IP release, maintaining momentum and accountability for key milestones

• Provide strategic input at Bid Defense and Kick-Off meetings, influencing study design and start-up feasibility from the outset

• Oversee regulatory and ethics submissions, ensuring high-quality, compliant, and timely approvals across regions

• Manage site contract and budget negotiations in collaboration with legal, finance, and sponsors, supporting timely site activation

• Proactively identify risks, dependencies, and bottlenecks, implementing mitigation and escalation strategies to protect study timelines

• Partner closely with Project Managers and cross-functional stakeholders, ensuring seamless integration of start-up within overall study delivery

• Ensure accuracy, quality, and inspection readiness of all study documentation, including oversight of CTMS and eTMF activities

• Lead and coordinate Study Start-Up team members, providing direction, support, and oversight to ensure consistent delivery

• Drive process consistency and continuous improvement across regions, contributing to operational excellence initiatives

• Maintain oversight of study metrics, budgets, and scope of work (SOW), ensuring delivery within agreed parameters

• Provide clear, structured reporting and updates to sponsors and internal leadership, enabling informed decision-making

Your Profile

• Proven, recent experience with Study Start‑Up (SSU) as a primary responsibility, including end‑to‑end ownership of site activation activities

• Experience delivering SSU across global or multi‑country clinical studies

• Strong knowledge of regulatory and ethics submission processes, including CA/EC and CTA strategy

• Experience coordinating site contracts and budgets within start‑up timelines

• Demonstrated ability to manage SSU timelines, risks, and competing priorities

• Hands‑on familiarity with CTMS, eTMF, and clinical trial systems

• Solid understanding of ICH‑GCP and applicable regulatory frameworks

• Strong stakeholder management and communication skills across sponsors, sites, and internal teams

• Ability to collaborate effectively across cross‑functional, global teams

• Structured, proactive, and solution‑oriented approach to delivery

#LI-KT1 #LI-Remote

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