Sr Manager, Site Activation - Medical Device and IVD based anywhere in EU

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:

Prepare/contribute to client and project specific site activation strategy and site activation plan for medical device and IVD studies and work cross-functionally to ensure that the sites and countries chosen optimize opportunities for successful delivery of the project for the benefit of both ICON and client.

Client Relations

• Ensure adequate oversight of project in terms of timely delivery of key timelines and that the impact of missed deliverables is understood by all key stakeholders.
• Attend client calls, where required and ensures that both the interests of ICON and the client are robustly defended.
• Manages the contribution of key study stakeholders to ensure optimum performance and cross collaboration.
• Create and maintain an environment of "trusted partner" which allows successful delivery of site activation through clear and open dialogue and use of "best practice" communication.
• Support directly/indirectly sales preparation calls including bid-defense and study kick-off meetings where required. Ensure that the client and study teams understand key timelines, deliverables and milestones and that there is a clear strategic site activation delivery plan as well as risks/mitigation and communication plans to ensure each study is set up for successful project delivery and that both the interests of ICON and the client are robustly and equally defended.

• Manage contribution of key study stakeholders to ensure optimum performance and collaboration. Create and maintain the environment which allows successful delivery of site activation activities via clear and open dialogue and communication strategies/tools.

• Foster and develop key relationships with clients and internal customers and where needed participate on customer satisfaction initiatives.

Operations/Line Management:

• Oversee day to day management of projects and personnel assigned to ensure each project has a strategic site activation delivery plan and that the study is being conducted in accordance with that plan and in an effective manner, meeting ICON/sponsor timelines and expiations and in adherence with ICON/client KPls, ICON/client SOPs, reporting norms, appropriate regulations and ICON's quality standards.

• Ensure effective resource planning and allocation of work assigned, including recruitment of high performing staff, line management of personnel within portfolio, ensuring and providing adequate training and training compliance, mentorship/coaching, career progression and succession planning. Agreeing and ensuring delivery of high quality performance and performance measurements. Ensure effective utilization and recovery of resources within portfolio.

• Identify, lead and input into process improvement initiatives across site activation activities. Ensure new initiatives are rolled-out and followed through. Coordinate effective cross-regional processes and procedures. Drive efficiencies and define strategies to overcome barriers to successful performance within portfolio and within the wider study start up group. Optimize operational efficiency through sharing & centralization of information and promotion of best practice within the portfolio and the wider group. Effectively manage change within the portfolio and drive innovation and continuous improvement in all areas of responsibility.

• Proactively manage the studies and personnel assigned, quickly identifying barriers to success and defining strategies and mitigation plans to ensure prompt return to successful performance where required.

• Provide effective management support to the resources within your portfolio and continue to encourage a high performing culture within the teams. Carry out all relevant line management responsibilities including appraisals, goal setting and development plans.

• Communicate openly and effectively with direct line-manager on all critical issues, business growth opportunities and prepare/review status reports versus client deliverables taking appropriate actions.

• Work closely with peers to ensure global consistency, focus and development are achieved in the successful execution of site activation activities globally.

• Function as a key, senior level liaison for site activation and study start up with clients, as appropriate.

What you need

• Bachelor’s degree or local equivalent in science or technology field preferred.
• Minimum 6 years Medical Device Study Start-Up experience that includes a minimum 4 years’ relevant experience as a Site Activation Manager, Study Start-Up Manager, CRA/SSU Manager or equivalent job role.
• Excellent management skills, developed with a collaborative approach to driving performance and success in a global environment
• Understanding of the Regulatory requirements for submissioacross Europe and UK
• Proven ability to train and mentor others on tasks and processes.
• Advanced knowledge of medical device and IVD regulatory requirements is preferred
• Direct experience managing Site Activation Leads and Study Start-Up Associates is preferred
• Experienced multi-tasker with the ability to manage multiple projects.
• Proven ability to lead people and organize processes and workflow

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, 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.

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