Project Manager, Feasibility Site Activation

ICON Clinical Research Ltd; Dublin; On-site; EUR 85,000 - 120,000; Full time

Job summary

ICON Clinical Research Ltd in Ireland is seeking a Project Manager - Feasibility & Site Activation to lead global start-up strategies and drive efficient site activation across regions. You will own the SSU process, navigate regulatory pathways, and partner with sponsors, internal teams, and sites to deliver start-up excellence from day one.

Responsibilities include developing Start-Up Plans, managing regulatory and ethics submissions, site contracts and budgets, risk mitigation, and reporting

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Recent SSU experience with end-to-end site activation.
• Experience supporting global multi-country trials.
• Strong knowledge of CA/EC submissions and CTA processes.
• Experience managing site contracts and budgets.
• Working knowledge of CTMS and eTMF systems.
• Solid understanding of ICH-GCP and regulations.

Responsibilities

• Shape and execute Study Start-Up strategies across global studies.
• Lead development and delivery of Start-Up Plans covering regulatory, ethics, and contracts.
• Drive end-to-end start-up activities from site identification to IP release.
• Provide strategic input at Bid Defence and Kick-Off meetings.
• Oversee regulatory and ethics submissions for timely approvals.
• Manage site contracts and budgets in collaboration with legal and sponsors.
• Identify risks and implement mitigation to protect timelines.
• Coordinate Start-Up team members and ensure consistent delivery.
• Drive process improvements across regions.

Skills

Project management

Stakeholder management

Regulatory knowledge

Communication

Education

Bachelor's degree in Life Sciences

Tools

CTMS

eTMF

Job description

About the role

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 Defence 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

• Bachelor's degree in Life Sciences or a related field.
• Recent Study Start-Up (SSU) experience with end-to-end site activation responsibility.
• Experience supporting global and multi-country clinical trials.
• Strong knowledge of CA/EC submissions, CTA processes, and regulatory requirements.
• Experience managing site contracts, budgets, and start-up timelines.
• Working knowledge of CTMS, eTMF, and other clinical systems.
• Solid understanding of ICH-GCP and applicable regulations.
• Strong stakeholder management, communication, and collaboration skills.
• Organized, proactive, and solution-oriented approach.

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

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.

Benefits: Work From Home TPBN1_IJ