Country Study Operations Manager - Home Based (US)
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
What you will be doing:
- 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
What you need to have:
- 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
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
