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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.

Services Overview:

The service holder provides leadership, direct oversight, coordination or support of assigned programs and projects within the department to ensure that all allocated activities and tasks are conducted per Janssen requirements. They will serve as a subject matter expert for assigned activities including the creation or enhancement of Partnership Support Document Packages, Processes and Training such as supplier operational manuals. Responsibilities include ensuring alignment to required procedural documents, a metrics and Key Performance Indicator (KPI) framework, related training materials and the development of the Janssen governance and oversight model.

The service holder supports the identification and evaluation of Partnership Behaviors and optimizes the commitment by creating training program for cross functional study teams and governance members. They interact and directly train cross functional study teams when onboarding new suppliers into framework and works collaboratively with Janssen suppliers.

Supplier types for development of Partnership Support Document Packages, Processes and Training include suppliers supporting Central Laboratory Services, eCOA, IRT, ancillary supplies, imaging, home healthcare, Integrated Data Analytics & Reporting (IDAR) and Alliance CROs.

All projects and activities assigned will be delivered in compliance with the applicable company Policies, Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), applicable Quality Oversight Plans (QOPs), regulatory requirements, local laws, and any department related requirements.

Deliverables:

Lead the development, enhancement and ongoing maintenance of assigned Partnership Support Document Packages, Training and Processes, serving as the subject matter expert and escalation point of contact.

• Take ownership of the roll out of new or updated assigned Partnership Support Document Packages, Training and Processes.

• Make use of dashboards and data visualizations to create, generate and share status reports and data- driven insights of assigned projects/initiatives. Highlight operational or technical roadblocks and proactively propose potential solutions.

• Deliver regular updates and insights to the departmental and Global Development leadership team.

• Manage stakeholder communications. Create and generate reports in various systems. Author guidance or knowledge articles and reports.

• Lead and manage assigned projects. Track project deliverables, timelines and provide escalation support.

Proactively direct activities to ensure deliverables and milestones are met. Identify risks and ensures mitigation and contingencies are being initiated and followed through.

• Optimize relationships with Janssen suppliers and cross functional teams to ensure delivery of key R&D

milestones.

• Be a strong advocate for the expected Partnership Behaviors, delivering training, remediation and mentorship as required.

• Identify and lead opportunities to conduct Lessons Learned to promote continuous improvement and outsourcing best practices across Global Development.

• Contribute to inspection and audits as a primary contributor

Education and Requirements:

• Bachelor’s degree is required.

• At least 5 years of experience in a Clinical Research environment working within the functional area that the Partnership Enablement Manager will support and with experience working directly with various suppliers.

• Project Management and Training/Mentoring skills, and strong analytical skills.

• A proven track record of working cross functionally within a global environment.

• Have strong verbal / written communication skills and ability to communicate across all levels of the organization.

• Demonstrated basic ability to influence without authority and manage change.

• Must be customer focused and can lead process improvement initiatives from an internal lens of time, cost and quality and through an external lens supplier.

• Must be proactive, and willing to challenge the status quo. Is able to manage change positively and sees change as an opportunity to improve processes and tools.

• Must have strong computer skills with an ability to understand, access and leverage technology.

• Knowledge of continuous improvement tools and application to business process are a plus.

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.