ICON Strategic Solutions
ICON Strategic Solutions Budapest Hungary
2 weeks ago
• 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 regulation
• Maintains the quality and scientific integrity of clinical trials at a country leve
• Collaborates with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial deliverables within the countr
• Maintains expert country, site and protocol knowledge to support sites with questions as well as build strong site relationship
• 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.
• 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 Amgen 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.
• Triages / tailors communication from study / local team to sites to ensure efficient and effective communication flow.
• 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
• Matrix team leadership
• Project Management skillset
• Critical thinking and horizon scanning
• Problem solving
• Decision making
• Delegation skills
• Relationship Management and influencing skills
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