Clinical Trial Manager

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.
• 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)

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