Project & Portfolio Oversight Leadership - Remote

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 Project Oversight Support/Lead provides direct oversight, support, and coordination for assigned programs and projects within the department to ensure that all assigned Janssen activities/tasks are worked on and/or escalated per Janssen procedures.

The service will proactively communicate to Janssen the status of the activities for assigned programs and projects to ensure services within scope are delivered according to Janssen expectation. The service also partners with Janssen to provide input to project/program assignments to support the portfolio and special projects. The service will lead cross-functional, matrixed teams to ensure deliverables, timelines and escalation support are provided. The service will serve as a subject matter expert for assigned program and projects. Services include providing, as a core member of the Departmental Team, program management and cross-functional operational leadership for the delivery of services.

Further, this service will oversee that all projects and programs are delivered in compliance with the assigned clinical trial protocol, applicable company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), Quality Oversight Plans (QOPs), regulatory requirements, and other department related requirements

Deliverables: 

• Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies,

local regulatory requirements, ICH-GCP, etc. 

• Deliver regular updates and insights to the departmental and leadership team of the status of projects/initiatives, highlighting operational or technical roadblocks and proactively proposing potential solutions for mitigation.
• Coordinates with the Departmental team members to ensure successful delivery of activities

and tasks within scope (including project specific deliverables, key milestones, timelines etc.)

and timely escalation and resolution of issues.

• Lead cross-functional, matrixed team; tracking project and program deliverables, timelines and provide escalation support. Proactively manages that deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through.
• Serves as a subject matter expert and escalation point for assigned program.
• Participates in and leads projects that advance department goals and objectives.
• Partners with Janssen Managers to review and provide input to portfolio and resourcing demand.
• Ensures documentation of team meetings, key decisions, action items, risks, and team

communications are maintained and updated appropriately.

Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP)

document.

 Interfaces – Primary/Other:

• Primary interfaces: Provider Functional Manager, Johnson & Johnson Point of Contact
• Other Interfaces: Global Development (Global Clinical Operations, Project Management

Organization, Portfolio Delivery Operations, Integrated Data Analytics & Reporting, etc), Therapeutic Areas, Procurement, Market Access, External Business Partners (for example, license holders, technology vendors, translation and printing vendors). For GSMO: GMSO, Global Clinical Operations, CRO Strategic Partnership Team, Users of Safety Portal, External Business Partners (for example, technology vendors,)

 Ed u catio n an d Ex p e rie n ce Re q u ire men ts/ Qu alif icatio n s :    

BASE (level 1)

• Bachelor’s degree (University degree)or equivalent education / relevant experience required
• At least 2 years operational experience in (safety reporting (for GSMO only) for) clinical trials

with a pharmaceutical company and/or a Clinical Research Organization is required

• Prior experience as an influential member of a cross-functional team is required
• Strong project management skills are required.
• Experience in mentoring and training
• Experience with team leadership/co-ordination in R&D functions is preferred
• Demonstrated knowledge of safety reporting (for GSMO), clinical development processes, global clinical operations, and/or strategic planning (not for GSMO) is required (depending on requesting function (EBIS, GSMO, …)
• Demonstrated knowledge of effective issue resolution and mitigation planning is required

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.