Site Start-up and Activation Compliance Manager

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.

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.

• Responsible 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 methodologies

• The 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 efficiency

• Identification of potential non-compliance of quality control steps taken by operations as measured by defined standards

• Regular spot-checks of key parameters to confirm compliance with internal systems and external requirements, and to ensure that processes function appropriately and consistently

• Supporting system owners and system end users to maximise compliance; validate updated system guidelines and ensure roll-out, comprehension, use and application

• Review of functional learning plans to ensure consistency and automation of assignments.

To be successful in the role you'll need:

• Minimum 5 years industry experience, within a health care or a clinical research environment and/or an auditing role

• Excellent leadership skills, developed with a collaborative approach to driving performance excellence and success

• Demonstrate the ability to be a critical thinker and be willing to question the way things are done to improve efficiency

• Ability to make analytical and data focused decisions in a fast-paced environment

• Flexible individual who is excited about the opportunities represented by change.

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.