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Site Start-up and Activation Compliance Manager

ICON Public Limited Corporation

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...

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.

The Role:

The Site Start-Up and Activation Compliance Manager role is essential for providing adherence to regulatory requirements and compliance to system usage, supporting the management of CAPAs, support to PMO for SOP design and for continuous process improvements across all functions of ICON's Global Site Activation and Country Study Start-Up.

Location: Any EU locationResponsible for ensuring the Site startup and Activation function adheres to internal and external measures of quality to prevent key audit findings.Oversight in adherence to processes, and documentation. Ensuring global consistency in following the SOPs and Work instructions.Seeks to deliver perfection and efficiency in operational delivery through dynamic, continuous improvement methodologiesThe Compliance Manager interacts with internal team members at all levels, as well as sponsor teams, and acts as a subject matter expert on topics pertaining to quality and compliance.

Typical activities (but not limited to) may include:Evaluation of process flow and content of functional SOPs for clarity, accountability and efficiencyIdentification of potential non-compliance of quality control steps taken by operations as measured by defined standardsRegular spot-checks of key parameters to confirm compliance with internal systems and external requirements, and to ensure that processes function appropriately and consistentlySupporting system owners and system end users to maximise compliance; validate updated system guidelines and ensure roll-out, comprehension, use and applicationReview of functional learning plans to ensure consistency and automation of assignments.

The ideal candidate we are searching for will need:Minimum 5 years industry experience, within a health care or a clinical research environment and/or an auditing roleExcellent leadership skills, developed with a collaborative approach to driving performance excellence and successDemonstrate the ability to be a critical thinker and be willing to question the way things are done to improve efficiencyAbility to make analytical and data focused decisions in a fast-paced environmentFlexible individual who is excited about the opportunities represented by change.

Benefits of Working in ICON:

Our success depends on the quality of our people. We offer very competitive salary packages. To keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both yours and ours. 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. Beyond the competitive salaries and comprehensive benefits, you will 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, 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 through the form below

Job posted: 2021-06-29

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