About this role
About the Role ICON seeks a Project Manager to oversee country-level study activities from startup through conduct and close, supporting Global Study Managers and the broader Study Management delivery. The PM may lead country-level work and provide local intelligence to inform strategy and critical path planning while ensuring high-quality delivery. What You'll Do
- Implement country/study Startup and Site Activation Plans and country-level Recruitment Strategy
- Develop and maintain study level plans; communicate with local teams, internal stakeholders and CROs to ensure timely delivery
- Manage country/vendor relationships and oversee vendor deliverables; coordinate regional/site QEs, PDs, data issues, metrics, site issues/risks, and audit responses
- Independently manage tasks with sound judgement; support startup activities in assigned countries/CROs; lead parts of projects or countries
- Act as Local Study Team lead; ensure compliance with Global/Local requirements and regulations; liaison with Health Authorities for submissions when needed
- Provide country-level input on milestones, budgets, risk, and quality; maintain country-level plans and ensure PTMF completeness and ISF reconciliation
- Ensure audit readiness, manage Quality Events with pCRO and local team; drive site recruitment planning; oversee data cleaning deliverables
- May act as Subject Matter Expert and lead operational effectiveness initiatives at country/regional level
- Support PTA, SIV reports and EC/RA submissions as required; drive PTMF setup and ISF completeness; manage IP/equipment/ancillary supplies
- Support implementation of new tools and technologies (eConsent, eISF, Remote Source Access) What We're Looking For
- Experience in study startup, site activation, and country-level study management; ability to coordinate with CROs and cross-functional teams
- Knowledge of ICH/GCP standards, SOPs, local regulations; audit readiness
- Strong communication skills; ability to provide local intelligence to Global Teams and liaise with Health Authorities
- Ability to manage budgets, timelines, risks, and quality plans
- Proactive, able to work independently and drive deliverables Nice to Have
- Subject matter expertise in country-level operational delivery and PTMF/ISF processes; familiar with PTMF, ISF reconciliation, and quality events
- Experience with eConsent, eISF, Remote Source Access tools