Local Trial Manager

·         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.

·         Responsiblefor 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