Country Study Manager
- Employer
- ICON GSS - EMEA
- Location
- Poland
- Salary
- Competitive
- Start date
- 21 Jul 2022
- Closing date
- 20 Aug 2022
View more
- Discipline
- Clinical Research, Clinical Trials Manager / Administrator
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
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)
- Accountable for study deliverables in that country.
- Leads country-level operational planning and supports site selection within assigned country
- Ensure effective study risk management for assigned country
- Contribute to development of study-specific materials - e.g. monitoring plan, study specific training documents
- Support and contribute to Trial Management Teams (TMTs), agenda driven presence at meetings and daily huddle as required
- Communicate country status (including timelines and deliverables) to key stakeholders (e.g. TMT, GCMs, Program Managers) and ensures updates to relevant systems
- Contributes to site-level goal setting and study-specific deliverables for clinical sites within their country
- Coordinates cross-functional review of issues escalated directly from sites or via the CRA and facilitates resolution
- Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training
- Provides country level input into the Country Operational Plan (COP) and partner with the DFM through feasibility and with the GCMs to ensure regional delivery of the study
- Monitor the execution of the clinical study against timelines, deliverables and budget for that country; 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
- Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range)
- Review Monitoring Visit Reports
Qualifications
Requirements:
- At least three years of experience on the similar position is mandatory
- Problem solving
- Decision making
- Delegation skills
- Relationship Management and influencing skills
Company
ICON is the leading provider of Functional Service Provision (FSP) globally. Our team of operational, functional and therapeutic specialists offer a range of FSP models that can be customised to deliver the most efficient operating model for your organisation. We bring a suite of capabilities, expertise and technology to augment your operations, increase R&D efficiencies and improve site engagement to access patient populations and deliver timelines and milestones. We have deployed FSP solutions across all major functions from clinical monitoring and project management through data management, statistical programming and beyond.
ICON FSP experience
- 90+ FSP partnerships
- 13,000+ Employees
- 90+ Countries
Functional areas
Our offering includes a range of globally scalable FSP solutions that are customised to provide support where and when you need it. We have significant experience in providing bespoke FSP solutions, particularly in:
- Study start-up
- Project Management
- Clinical monitoring
- Pharmacovigilance / Safety
- Clinical Supplies Management
- Data management
Biostatistics and programming
Contracts management
- Investigator payments
- Clinical vendor management & category management
- Medical writing
- Medical affairs
- Regulatory affairs
- Regulatory publishing
- Website
- https://careers.prahs.com/
- Location
-
500 South Oak Way
Green Park
Reading
Berkshire
RG2 6AD
United Kingdom
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