ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST).- Supports country-level operational planning and accountable for site selection within assigned country/-ies.
- Contributes and develops to program/study-specific materials – e.g., monitoring plan, study specific training documents.
- Supports and contributes to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable, agenda driven, present at meetings.
- Communicates country status (including timelines and deliverables) to key stakeholders (e.g., Global Clinical Managers [GCM], Program Managers, CST or TMT, Development Operations Manager [DOM] etc) with oversight as required and ensures updates to relevant system
- Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/-ies.
- Contributes to, deliver and/or lead CRA, Investigator and Study Coordinator trainin
- Provides oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisionin
- Engages with local cluster team and local functions from a study perspective (e.g., Local Medical Affairs team, DOM).
- Provides country level input into the Country Operational Plan (COP) and partner with the DFM through feasibility and with the GCMs to ensure local delivery of the stud
- Responsible for approval of Baseline and Revised Enrolment Plans (Country Level).
- Contributes to the study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment long-range estimates) process.
- Monitors the execution of the clinical study against timelines, deliverables, and budget for that country.
- Translates global start up requirements into local country targets
- Monitors country enrolment and retention and act on deviations from plan. Identify barriers to enrolment and support recruitment and retention strategic solutions.
- Monitors and acts upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate.
- Monitors and reviews country and study trends.
- Reviews Monitoring Visit Reports.
- Identifies and facilitates resolution of cross-functional study-specific issues.
- Provides updates regarding the study budget and obtains approval for budget deviations for clinical sites (outside of range).
- Escalates any issues related to delivery, timelines, or budget to GCMs (or TMT le ad if appropriate).
- Escalates CRA performance issues to applicable Clinical Trial Oversight Manager.
- Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of investigator site relationships.
- Executes regulatory agency inspection readiness activities (e.g., TMF review, story board generation).
- Supports internal audit and inspection activities and contributes to CAPAs, including leading resolution of issues when appropriate e.g., vendor management.
- Participates in cross-functional task forces/process improvement groups
- Assigns and oversees deliverables of study support staff e.g., Study Management Associate, ASM/SASM (Snr./Assc. Study management) and continually reviews country level risk mitigation to ensure study delivers to plan.
- Collaborates with local teams to ensure country level study delivery is aligned with global expectations.
- Coordinates of the site contracting, budgeting, insurance and payment process by overseeing local support roles (e.g., CTA, SCBA, Legal).
- Identifies risk, implementing risk mitigation strategies, and resolving issues at a country/site level, as well as informing the CST / TMT, LST and local teams of risks associated with delivery in a proactive, timely and solution orientated manner. Contribute to study-level risk assessments.
- Leads and continually reviews country level risk mitigation activities to ensure study delivery to plan.
- Maintains relevant therapeutic knowledge.
Knowledge:
- Local knowledge / expertise of regulatory environment, study start up process and associated timelines etc.
- Clinical trial processes and operations
- Extensive knowledge of ICH/GCP regulations and guidelines
- Project and Program management experience including oversight of study deliverable, budgets and timelines
- Time, cost and quality metrics, key performance indicators (KPIs)
- Relevant Therapeutic knowledge is preferred
Key Competencies:
- Matrix team leadership
- Project Management skillset
- Critical thinking and horizon scanning
- Problem solving
- Decision making
- Delegation skills
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.
