Clinical Trial Manager

As a Clinical Trial Manager, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence

JOB SUMMARY

• 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.

RESPONSIBILITIES

• Planning, management, and oversight of clinical study execution in accordance with the global
• program strategy, through leadership of the cross-functional Local Study Team/ Supports country-level operational planning and accountable for site selection within assigned Country.
• Contributes and develops to program/study-specific materials – e.g., monitoring plan, study specific training documents.
• Supports and contributes to Clinical Study Teams/ Trial Management Teams as applicable, agenda driven, present at meetings.
• Communicates country status (including timelines and deliverables) to key stakeholders with oversight as required and ensures updates to relevant systems.
• Accountable for site-level goal setting and study-specific deliverables for clinical sites
• Contributes to, deliver and lead CRA, Investigator and Study Coordinator training.
• Provides oversight and monitoring of applicable vendor activities
• Provides country level input into the Country Operational Plan (COP).
• 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.
• 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 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 clinicasites (outside of range).
• Escalates CRA performance issues to applicable Clinical Trial Oversight Manager.
• Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance 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.
• 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.

• Min. BA/BS/BSc
• Min. 1 year experience as local CTM (mandatory)
• 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)

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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, colour, 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.

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