Local Trial Manager

Overview

• 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.

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 (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.

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Qualifications

Knowledge:

·         Local Hungarian knowledge / expertise of regulatory environment, study start up process and associated timelines etc.

·         Clinical trial processes and operations and trial management experience 

·         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