Senior Manager, Study Start-Up

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 Lead SAM supervises a team of Study Start-Up Leads (SULs) to ensure all deliverables related to site activation are achieved for their allocated countries/projects as specified in the Client Contract and/or Work Order. The Lead SAM provides project oversight performing deliberate and scheduled review of country/project progress and/or risks in support of assigned SULs. To further support site activation the Lead SAM is assigned to specific projects or programs to enable account oversight including participation in Global Project Review meetings. The Lead SAM provides leadership in the implementation of PRA’s quality initiatives and business operations, achievement of its management goals and objectives within the framework of the company mission, policy and philosophy and works alongside the Director and Associate Director of Clinical Operations to improve on PRA’s Study Start-Up processes and systems.

• Provides support with proposal development and represents Study Start-Up in bid defenses.
• Provides start-up resources as determined by the scope of work per project.
• Performs regular review of the relevant milestones and resource utilization per project.
• Evaluates compliance with regard to PRA systems and processes.
• Provides functional management support to direct reports, including professional development, performance appraisals and employee counseling/mentoring.
• Manages and co-ordinates resources and reviews workload of direct reports.
• Identifies direct report training needs and ensures all of these are met.
• Supports the SULs on assigned projects in:
• Development of their strategies and plans for site activation
• Running study reports and preparing Sponsor updates
• Implementation of the PRA Study Start Up Methodology

In addition to the accountabilities listed above:

• Provides consultation for internal/external clients regarding strategy and/or plans for site activation.
• Identifies and responds appropriately to issues and problems, providing innovative solutions.
• Supports business development activities.
• If required, attends face-to-face bid defense meetings.
• May have functional management responsibilities for Manager of Study Start Up at Level 1.
• Provides training to other Functional Areas on Study Start Up tools and planning.
• May present or represent PRA at professional meetings.

• Minimum of 8 years prior experience within a clinical role – for example Clinical Operations, Study Start Up, Clinical Team Manager.

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.