Country Study Operations Manager- Remote

About the Role ICON is seeking a Country Study Operations Manager - Remote to lead and coordinate the country/regional study execution, ensuring studies are delivered on time, within budget, and to high quality standards. You will oversee study startup through conduct and close, collaborate with pCRO/Country Trial Manager, Site Care Partner, and global teams, and ensure regulatory readiness and risk mitigation.

What You'll Do

• Manage/oversee study and regional/country level activities from startup through conduct and close.
• May manage startup in countries assigned or oversee pCRO for startup activities.
• Support outreach, site identification, and feasibility to ensure sites meet protocol requirements.
• Provide country-level input on Startup and Recruitment milestones to Global Study Manager during planning.
• Oversee pCRO/Country Trial Manager/Site Care Partner for assigned studies at country level; maintain country-level plans (timelines, budget, risk, quality).
• Collaborate with accountable roles to identify deviations and risks and implement mitigation strategies; resolve Site Activation escalations with options for mitigation.
• Lead the Local Study Team (core members: Lead Site Care Partners; ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required).
• Ensure compliance with global/local requirements and regulations; ensure timely bidirectional communication between global and local study teams.
• Provide protocol-level guidance to Local Study Team; liaise with regulatory colleagues on submission strategies.
• Use country roles to provide local intelligence and operational nuances to Global Teams.
• Act as study-level point of contact for all study-level questions; escalate when needed and liaise with global roles/teams.
• Follow up on issue status; identify country-level trends to improve processes.
• Provide input on Investigational Quality Management Plan and Study Monitoring Plans; ensure PTMF completeness; oversight of compliance activities.
• Ensure audit/inspection readiness during start-up and conduct; manage Quality Events with pCRO and local team as applicable.
• Coordinate site recruitment planning; ensure alignment with global and local targets.
• Drive and ensure delivery of data cleaning deliverables for pCRO and sites; provide input on country-level costs and vendor costs.
• May act as Subject Matter Expert; lead operational effectiveness initiatives at country/regional level.
• Responsible for PTA and SIV report review; supports Site Technology Experience systems (SIP, CAM).
• Support regulatory submissions and deficiency/query responses for initial and subsequent CTA submissions within required timelines.
• Drive PTMF setup and oversee ISF reconciliation/completeness; manage IP/equipment/ancillary supplies with import/export licenses as needed.
• Support new tools and technologies (eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, decentralized trial options).
• Support vendor identification, contract development, and management of local facilities per protocol.
• Investigator Meeting support and management; presentation delivery as appropriate.

What We're Looking For

• A scientific or technical degree preferred; knowledge of clinical trial methodology.
• BS/BSc/MS/MSc degree required; BA/BS acceptable.
• 5+ years of relevant experience in operational clinical trials.
• MBA/MS with 3+ years of relevant operational clinical trial experience.
• Working knowledge of Good Clinical Practice and clinical/regulatory operations in countries under responsibility.