DOCS Operations Manager
ICON
North Wales
6d ago

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation : Accountability & Delivery, Collaboration, Partnership and Integrity.

We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point.

In short, to be the partner of choice in drug development. That's our vision. We're driven by it. And we need talented people who share it.

If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

Summary

The Bioanalytical Project Coordinator provides administrative support to the Bioanalytical Study staff for pre-clinical and clinical studies.

  • This includes, but it not limited to, project related support by creating database designs supporting small or large global projects with low complexity;
  • ensuring database set up according to standard operating procedures, policies, and good practice; and compiling project data tables according to client data agreements.

  • Line manages all assigned G-CTA (Study-facing) as per requirements of role, including
  • performance management.
  • Ensure G-CTA (Study-facing) resources are identified and assigned as necessary to
  • support Janssen clinical trials.
  • The G-CTA Program Lead and Janssen FM will define resource needs / requirements and
  • interact with G-CTA FM to review current situation per portfolio.
  • Partner with G-CTA Program Lead to assign G-CTAs (Study-facing) per needs of theand distribution of tasks to the supporting G-CTAs (Central)).
  • Janssen portfolio (i.e., G-CTA (Study-facing) work assignments, workload requirements
  • Support G-CTA (Study-facing) delivery of trial and / or activity-specific milestones on timeapplicable regulatory requirements (G-CTA FM will be trained on all relevant Janssen
  • and within budget with quality and in compliance with all relevant SOPs, policies and
  • SOPs)
  • Support operational and process definition for the function.
  • Partner with G-CTA FMs and G-CTA Team Leads (TL) to identify, interview, on-board,
  • and train staff per company-specific standards / expectations and trial specific
  • Support inspection readiness activities. Align with Janssen-led activities to coach G-CTAwhich could result in a Corrective And Preventive Action (CAPA)
  • We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors.
  • Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

    But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

    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.

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