About the Role
As a Project Manager, Feasibility and Site Activation (FSA) at ICON, you will be responsible for planning and managing Feasibility and Site Activation (FSA) activities for assigned clinical studies. You will oversee site start-up and activation workstreams, ensuring deliverables meet quality and timeline expectations.
Responsibilities
- Oversee site start-up and activation workstreams, ensuring deliverables meet quality and timeline expectations.
- Develop and manage FSA project plans, timelines, and deliverables for assigned studies.
- Coordinate feasibility assessments, country and site recommendations, and start-up strategies in collaboration with functional experts.
- Oversee essential document collection, ethics and regulatory submissions, and site activation milestones.
- Track progress against timelines and KPIs, proactively identifying risks and implementing mitigation plans.
- Serve as the primary FSA contact for internal teams and customers for study-level start-up matters.
- Contribute to process improvement and best practice sharing within the FSA project management team.
- Oversee the start-up milestones for each site, managed by the Site Specialist/Site Contract Negotiator after site selection.
- Manage and lead all aspects of the start-up phase (budget, resources, Site Activation plan creation/management, etc.) to ensure successful Site Activation within schedule.
- Liaise with internal teams and stakeholders, and as needed, with sponsor teams and stakeholders to resolve issues and respond to customer expectations.
- Respond to audits and inspections as the FSA (Site Activation Lead).
Requirements
- Solid site start-up and activation experience.
- Ability to manage competing priorities and develop your team.
- Bachelor's degree in life sciences, healthcare, business, or a related field, or equivalent experience.
- Strong experience in clinical research with a focus on feasibility, site activation, or start-up project management.
- Proven ability to manage project plans, timelines, and cross-functional coordination in a fast-paced environment.
- Good understanding of regulatory, ethics, and contractual requirements affecting study start-up.
- Excellent communication, organisational, and stakeholder management skills.
- Detail-oriented and proactive, with a commitment to quality, predictability, and customer satisfaction.
- Willingness to travel as required (approximately 10%).
- Experience in leading or supporting clinical trial start-up, including budget/resource management and Site Activation Plan creation/management.
- Experience as a PM or CTM.
- Business-level English proficiency.
- Must have the legal right to work in the country where the role is based.
Skills
- Feasibility
- Site Activation
- Project Management
- Clinical Research
- Stakeholder Management
- Communication
- Organisation
- Detail-oriented
- Proactive
Location
- Tokyo
- Osaka
Work Type
- Office Hybrid
- Home
Experience Level
- Lead
- Support
Education Level
- Bachelor's degree in life sciences, healthcare, business, or a related field, or equivalent experience.
Benefits
- 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
About the Company
- 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.
- ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide.
- You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live.
Equal Opportunity
- 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.
