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Global Study Manager - CAR-T

Employer
ICON Strategic Solutions
Location
Poland, United Kingdom
Salary
Competitive
Start date
17 Apr 2024
Closing date
24 Apr 2024

View more

Discipline
Clinical Research, Clinical Study Manager
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We have an opportunity for a Global Study Manager who is responsible for supporting the delivery of clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the exact nature of the clinical program, so a high degree of flexibility is required. This particular role is with the CAR-T therapeutic area.

  • Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.
  • Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.
  • Manage the set-up of third-party vendors assessing initial statement of work and budget, as well as the change order process.
  • Provide input to data management documents (e.g. Case Report Form, Data Validation
  • Specifications), and interface with data management representatives and sites to facilitate the delivery of study data.
  • Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.
  • Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.
  • Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.
  • Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.
  • Assist in the clinical trial insurance process; track approvals, revisions and renewals of certificates.
  • Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.
  • Support risk management and quality efforts to ensure study compliance.
  • Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.
  • Prepare presentation material for meetings, newsletters and websites.
  • Support the study team in the implementation of audits and regulatory inspections.
  • Contribute to review of new/amended/unique SOPs and guidance documents.


Essential:
  • GSMs must have strong working CAR-T experience (an understanding of the clinical application and aspects of CAR-T Cell Therapy).
  • Must be based in UK, Poland or Spain
  • University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience
  • Minimum of 3-4 years of progressive clinical trial experience
  • Global Clinical Trial Management experience
  • Experience of working with and delivering through strategic partners and 3rd party vendors


What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others


Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

ICON, including subsidiaries, 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, colour, 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 or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there’s eve

Company

As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond.

ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world’s leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact.

Why choose a career with ICON Strategic Solutions?

Meaningful Work: You’ll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives.

Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally.

Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently.

Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization.

Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.

Company info
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