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.
We are currently seeking a Country Study Operations Manager to join our diverse and dynamic team. As a Country Study Operations 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
Through the Site Care Partner/Country Trial Manager or pCRO 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 as provided by pCRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning
Is 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, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans)
Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation
Leader of the Local Study Team (core members: (Lead) Site Care Partners Clinical Trial Assistant, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required)
Ensures 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 to Health Authorities and Ethic Committees
Utilize roles in countries such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered
Acts as the study level point of contact for all study-level questions for the Local Study Team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams
Follows up on region/country level issue status to ensure resolution.
Identifies country level trends to improve deliverables processes as needed
Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies
Ensures audit/Inspection readiness during start-up and conduct
Manages applicable Quality Events with pCRO and local team as applicable and required
Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets
Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicable
Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable
May act as a Subject Matter Expert
May lead operational effectiveness initiatives at country or regional level
Responsible for PTA and SIV report review for reports completed by the Site Care Partner
Supports implementation of client’s Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM)
Support to EC/RA and other relevant (e.g. radiation, biobank) submissions and deficiency/query responses for initial and subsequent CTA submissions within required timelines
Drives pCRO and/or applicable internal study team members to ensure PTMF set up meets study requirements, and maintains oversight of PTMF completeness
Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions
Ensure pCRO and/or applicable internal study team members maintain appropriate level IP/equipment/ancillary supplies management including Import/Export License management with the support of Clinical Trial Assistants and other roles as required
Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, implementation of protocol required decentralized trial options etc.)
Support Identification, contract development and management of local vendors or facilities as per protocol
Investigator Meeting support and management including doing presentations as appropriate
Management of local Investigator Meetings including doing presentations as appropriate
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 experience operational clinical trial experience
MBA/MS/ 3+ years of relevant experience 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
Demonstrated experience in managing country level operational activities and/or vendors
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
Effective verbal and written communication skills in relating to colleagues and associates both
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
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 .
