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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.

Principal Clinical System Lead

The Principal Clinical System Lead role is an exciting opportunity to join a leading Healthcare Intelligence Organisation and manage the oversight of EDC and technology setup and implementation. As a Principal CSL, you will act in a client facing, matrix management role, leading a team of Designers, Programmers and Validation Analysts to deliver a high-quality EDC and associated clinical system components from protocol through to go-live. In addition, the CSL will support mid-study changes and work closely with other Clinical Data Science lead roles to successfully deliver to our clients.

Functional Knowledge:

•Advanced knowledge of Clinical Data Science activities (CDMS', data ingestion, review and extraction, risk management and analytics).

Advanced technical understanding of relational databases and how they function and be able to create complex data flow diagrams

• Advanced skills in project management, including the predictive elements of timelines, resource requirements, financial tracking and analysis

• Advanced knowledge of one or more Clinical Data Management Systems and/or Electronic Data Capture systems

Business Expertise:

• Advanced understanding of protocol content and interpretation of efficient data collection requirements, both considering user experience and relational dataset structures

• Advanced ability to strategically react and adapt to changing requirements, processes and timelines in an agile, efficient and cost effective manner

• Develop and present advanced solutions for and at Bid Defense meetings

• Performs quality control peer reviews of CRFs and records comments appropriately

• Tracks and keeps functional management and those responsible for project management informed of any issues that might affect project target dates, scope or budget and escalates potential problems effectively and in a timely manner.

• Works independently and with other project leads, as needed, to negotiate timelines and key deliverables with clients and/or external customers and departments.

• Contributes to the oversight and management of system integration set up and vendor interactions where needed

• Understand project level revenue recognition/forecasting process and provides input regarding actual and forecasts units/hrs (revenue and resources) to the CDSPM.

• Other responsibilities may be assigned as required

Leadership:

• Functional Team Lead and primary point of contact for internal and external project team for CDS Systems (CDSS) for external and internal customer teams for assigned study/studies

• Ensure and maintain communication with all stakeholders regarding project status and priorities

• Lead and guide multiple technical teams of programmers, designers and data validation analysts (technical testers) to achieve common project goals.

•Leads teams in the internal UAT of configured System solutions, as needed

• Proactively take ownership of situations requiring leadership, and drive to end solution

• Embrace and contribute to a culture of process improvement with a focus on streamlining processes and adding value to the business and client needs.

• May independently supervise, including direct line management, a limited number of junior level individuals and deputise in place of the functional manager.

• Travel (approximately 15 %) domestic and/or international

• Typical years of experience 8+ An equivalent combination of education, training and relevant experience may be considered in place of the education and experience stated

Problem Solving:

• Use existing procedures to solve problems where solutions are not readily apparent; analyse information and standard practices to make judgement calls

• Develop and produce optimal solutions for specific project and/or database requirements across different sections of the study team

• Develop, enhance and drive forward thinking thought process ensuring deliverables to time and quality

• Feed into, own and develop efficient process improvements

Impact:

• Take personal ownership to drive, develop, report and analyse achievements of project goals

• Ability to move seamlessly between different tasks, studies and individual teams to drive project goals to effect the end product

Interpersonal Skills:

• Excellent written and verbal communication skills

• Adapts delivery style to cater for knowledge and understanding levels of individuals or teams to ensure key messages and considerations are delivered without ambiguity

• Proactive personal ownership across study teams, both within a project or across projects, to ensure consistent understanding

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 through the form below.

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