Manager, Clinical Systems

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.

As Manager of Clinical Systems (eCOA), you will get the opportunity to work with the industry’s largest vendors, build your knowledge of eCOA, and be part of project teams delivering some of the largest and most important clinical trials in the industry.

What will you be doing?

• Responsible to own the implementation of eCOA on trials run by ICON PLC.
  • Leads study-specific eCOA technology deployment and management strategies for internal GCDO stakeholders and externally across functions and service providers 
  • Participates and collaborates with key process partners (e.g., Clinical Supplies, Biostatistics, Vendor Management, Procurement) in the sourcing, evaluation and audit/qualification of eCOA vendors
  • Collaborates with GCDO Training & Communications group to define and maintain a training strategy for technologies
  • Acts as GCDO's eCOA SME and project manager for study deployment projects
  • Leads study teams in development of study-specific user requirements specifications documents and user acceptance testing (UAT) protocols and  execution. Ensures Good Documentation Practices are followed
  • Provides support to study teams to resolve eCOA ssues during the conduct of the study.
• Collaborates with study team during the protocol development process to understand requirements for IRT technologies
  • Effectively manages operational delivery with eCOA service providers; collects issues and trends from study teams; proactively works with Vendor Management and IRT vendors for issue resolution and prevention
  I• Collaborates internally and with eCOA service providers to implement standards on both system design and data reporting
• Ensures the availability and delivery of training programs for relevant internal staff
• Collaborates with and supports other teams by streamlining data flow between IRT and other GCDO systems (e.g. CTMS, Data Warehouse, Clinical Gateway, Clinical Supplies Management System)
  • Ensures trust through transparency in communication and individual actions; ensures outcomes are organizationally driven rather than individually driven; promotes collaborative organizational success.
  • Develops strategies to prioritize and deliver eCOA related initiatives in coordination with multiple internal departments 
• Coordinates evaluation and impact assessment of changes in the eCOA landscape and makes recommendations for actions
  • Provides support to teams on audit-related issues for eCOA services
• Ensures audit and inspection observations are evaluated and remediated in conjunction with the study team

Qualifications

• 4+ years of relevant experience in Clinical Research or a technology-related role within the Pharmaceutical, CRO, or technology vendor industries.
  • Experience with technology evaluation, deployment, and project management.
  • Strong knowledge / experience with eCOA systems and their function within clinical trials.

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, 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, 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.