[Hiring] Country Study Operations Manager @ICON plc

Role Description

As a Project Manager at ICON, you will be responsible for leading and coordinating project activities, ensuring that projects are delivered on time, within budget, and to the highest quality standards. Your role will involve overseeing all aspects of project execution, from planning and resource management to stakeholder communication and risk mitigation.

• Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close.
• May manage the study start-up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable.
• Supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements.
• Provides country level input on Startup and Recruitment milestones to Global Study Manager during planning.
• Accountable for overseeing pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan.
• Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution.
• Leader of the Local Study Team, ensuring compliance to relevant Global and Local, internal and external requirements and regulations.
• Ensures timely communication bidirectionally between the global and local study team.
• Provides protocol level guidance and support to responsible Local Study Team members as applicable.
• Liaise with Site Care Partner, Lead Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy.
• Acts as the study level point of contact for all study-level questions for the Local Study Team.
• Follows up on region/country level issue status to ensure resolution.
• Identifies country level trends to improve deliverables processes as needed.
• Ensures audit/Inspection readiness during start-up and conduct.
• Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level.
• Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicable.
• May act as a Subject Matter Expert and lead operational effectiveness initiatives at country or regional level.
• Supports implementation of client’s Site Technology Experience systems.
• Supports implementation of new tools and technologies.
• Management of local Investigator Meetings including doing presentations as appropriate.

Qualifications

• A scientific or technical degree is preferred along with knowledge of clinical trial methodology.
• BS/BSc/MS/MSc degree required.
• BA/BS 5+ years of relevant operational clinical trial experience.
• MBA/MS/3+ years of relevant operational clinical trial experience.
• Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility.
• Demonstrated clinical research experience and/or study management/startup project manager experience.
• Experience in Study and Quality management and working in a matrix management environment.
• Expertise in the use of study/site dashboard and reporting tools.
• Detail oriented & possesses technical expertise.
• Ability to manage moderately complex processes.
• Ability to operate in a matrix environment.
• Risk Identification & Mitigation.
• Strategic Planning, Analytical and Problem-Solving Skills.
• Critical Path Analysis.
• Excellent communication skills, both written and verbal.
• Ability to adapt to changing technologies and processes.

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.
• Benefits may vary depending on role and location.