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Full-time
Competitive base salary, Performance related incentives, Medical coverage, Dental coverage, Vision coverage, Retirement plans
Posted 12d ago
~40 hrs/week
Remote in Bengaluru, Karnataka, India
Responsibilities
The Project Manager will lead the end-to-end Study Start-Up strategy, ensuring efficient site activation, regulatory compliance, and timely milestone delivery. They will manage cross-functional collaboration, site contract negotiations, and risk mitigation to ensure clinical studies are positioned for successful execution.
Requirements
Candidates must have proven experience in Study Start-Up for global clinical trials, including deep knowledge of regulatory frameworks and site activation processes. Strong proficiency in clinical trial systems like CTMS and eTMF, along with excellent stakeholder management skills, is required.
Full 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.
Are you a current ICON Employee? Please click here to apply
Related keywords
Study Start-UpClinical Research OrganisationSite ActivationRegulatory PathwaysEthics SubmissionsContract NegotiationBudget ManagementCTMSeTMFICH-GCPClinical TrialsRisk MitigationStakeholder ManagementBid DefenseOperational ExcellenceProject Management
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.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
Medical DeviceTherapeuticsGovernment and Public Health SolutionsClinical Research ServicesCommercialisation and OutcomesOncologyValue Based HealthcareClinical TrialsPatient RecruitmentInnovation