Local Trial Manager
at Icon plc
Budapest, Közép-Magyarország, Hungary -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 18 Jun, 2024 | Not Specified | 19 Mar, 2024 | N/A | Oversight,Metrics,Operations,Key Performance Indicators | No | No |
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US Citizen | Student Visa |
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Employment Type:
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Contract to Hire – Corp 2 Corp |
Description:
- 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 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
Responsibilities:
Please refer the Job description for details
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
Budapest, Hungary