Local Trial Manager
- Latvia
- ICON Strategic Solutions
- Clinical Trial Management
TA Business Partner
- Icon Strategic Solutions
About the role
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- 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. |
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 · Relationship Management and influencing skills |
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