Country Study Manager

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.

Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up (COLA) to close out at a country level in accordance with ICH-GCP and other applicable local regulations. Maintains the quality and scientific integrity of clinical trials at a country level. Collaborates with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial deliverables within the country. Maintains expert country, site and protocol knowledge to support sites with questions as well as build strong site relationships. Partners with global, local country teams and study team to provide high level country strategy, drive study progress and country level study delivery. Accountable for study deliverables and drives key decisions within set country.

What you will be doing:

• 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 systems.
• 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 training.
• Provides oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning.
• 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 study.
• 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 Client 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 proactivetimely 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.
• Triages / tailors communication from study / local team to sites to ensure efficient and effectivecommunication flow.

You are:

• Undergraduate degree or international equivalent in clinical, science, or healthrelated field from an accredited institution; health care professional licensure,
• Advanced knowledge of global clinical trial management
• Minimum 2-3 years’ experience of leading local/regional or global teams 
• Minimum 2-3 years’ clinical trial project management experience
• Minimum 7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
• Must be a local/country expert with identifiable project management experience locally
• Builds strong site relationships as well as other local relationships to ensure end to end study delivery is met.
• Fluency in local language and business English

* Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. Why ICON:At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with varied skills, perspectives & backgrounds working together across 40 countries. 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.Interested in the role, but unsure if you meet all 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 role.