Country Study Manager

Employer
ICON GSS - EMEA
Location
Poland
Salary
Competitive
Start date
21 Jul 2022
Closing date
20 Aug 2022
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Job Details

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

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
Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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
Find Us
Website
Location
500 South Oak Way
Green Park
Reading
Berkshire
RG2 6AD
United Kingdom
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