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(Sr) Project Manager, Feasibility Site Activation

Role overview

Qualifications

  • Proven, recent experience with Study Start‑Up (SSU) as a primary responsibility
  • Strong knowledge of regulatory and ethics submission processes
  • Demonstrated ability to manage SSU timelines, risks, and competing priorities
  • Solid understanding of ICH‑GCP and applicable regulatory frameworks

Responsibilities

  • Shape and execute Study Start-Up strategies across global studies
  • Lead the development and delivery of comprehensive Study Start-Up Plans
  • Drive end-to-end start-up activities from site identification through to IP release
  • Partner closely with Project Managers and cross-functional stakeholders

Key facts

Other skills

  • Communication
  • Collaboration
  • Problem Solving

About the company

ICON plc logo

ICON plc

Contract Research Organizations (CRO)

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

Company details

Company typeXLarge
IndustryContract Research Organizations (CRO)
Company size10001

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Job description

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


Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our careers site to read more about the benefits ICON offers.


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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Marcus Rivera

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