Key Purpose:
？？ 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
？ Maintain the quality and scientific integrity of clinical trials at a country level.
？？ Collaborate with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial deliverables within the country
？？ Maintain expert country, site and protocol knowledge to support sites with questions as well as build strong site relationships
Key Activities:
？？ Partner 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)
？？ Contribute and develop to program,/study-specific materials – e.g., monitoring plan, study specific training documents.
？ Support and contribute to Clinical Study Teams (CSTs) / Trial Management Teams
(TMTs) as applicable, agenda driven, present at meetings.
？？ Communicate country status (including timelines and deliverables) to key stakeholders (e.g., GCMs, Program Managers, CST or TMT, 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)
？ Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training
？？ Oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning
？ Engage with local cluster team and local functions from a study perspective (e.g., Local
Medical, 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
？ Accountable for approval of Baseline and Revised Enrolment Plans (Country Level)
？？ Contribute 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
？？ Monitor the execution of the clinical study against timelines, deliverables, and budget for that country:
？ Translate global start up requirements into local country targets
？？ Monitor country enrolment and retention and act on deviations from plan. Identify barriers to enrolment and support recruitment and retention strategic solutions.
？？ Monitor and act upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate
？ Monitor and review country and study trends
？ Review Monitoring Visit Reports
？ Identify and facilitate resolution of cross-functional study-specific issues
？？ Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range)
？ Escalate any issues related to delivery, timelines, or budget to GCMs (or TMT le ad if appropriate)
？ Escalate CRA performance issues to applicable line manager.
？？Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships
？？ Execute regulatory agency inspection readiness activities (e.g., TMF review, story board generation)
？？Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g., vendor management
？ Participate in cross-functional task forces/process improvement groups
？ Assign and oversee deliverables of study support staff e.g., Study Management Associate, CTS , SASM (Snr. Assc. Study management)
？ ？Collaborating with local teams to ensure country level study delivery is aligned with global expectations
？？ Coordination of the site contracting, budgeting, insurance and payment process by overseeing local support roles (e.g., CTA, SCBA, Legal).
？？ Identifying 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-levelrisk assessments.
？？ Leading and continually reviewing country level riskmitigation activities to ensure study delivery to plan
？ Maintain relevant therapeutic knowledge
？？？？？？？？Triage / tailor communication from study / local team to sites to ensure efficient and effective communicationflow.
Basic Qualifications:
？ Doctorate degree OR
？ Master’s degree 3 years of directly related experience OR
？ Bachelor’s degree & 5 years of directly related experience OR
？ Associate’s degree & 10 years of directly related experience OR
？ High school diploma / GED & 12 years of directly related experience
？ Advanced knowledge of global clinical trial management
Preferred Qualifications:
？ BA/BS/BSc
？ Minimum 2-3 years’ experience of leading local/regional or global teams
？ Minimum 2-3 years’ clinical trial project management experience
？？？？？？？？？7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
？？？Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
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 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
? Cross functional team leadership - a team player with the ability to take initiative and lead
? Ability to work effectively in a team/matrix environment on multiple projects
? Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
? Risk management skills
? Strong organizational, self-management and planning skills
? Strong verbal reasoning, attention to detail, critical thinking, problem solving and analytical abilities
? Excellent interpersonal skills and effective communication across all levels within an organization
? Data analytics skills – using data to enhance performance and delivery
? Strong oral and written communication skills
? Time management
? Business English
? Delivery and risk focused
? Adaptability and Flexibility
? Demonstrable ability to work effectively cross-culturally and in a virtual work environment
? Strong IT computer literacy, including word processing, presentation, and spreadsheet applications