Manager, Clinical Operations

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.

What will you be doing?

The Manager of Clinical Operations is responsible for recruitment, growth, and development of Clinical Operations employees, which may include Clinical Team Managers (CTM) or Clinical Research Associates (CRA). They provide leadership in the implementation of PRA’s quality initiatives and business processes, as well as achievement of its management goals and objectives within the framework of the company mission, policy and philosophy.

Manage and develop PRA employees to ensure high quality work performance and retention of high quality employees. Specific accountabilities may vary by area of expertise:

• Develops plans to support growth and career development of assigned Clinical Operations employees as well as manage the delivery of quality performance in line with their job description.
• Ensures staff development and performance feedback are provided through activities such as mentorship and career development
• Communicates team and individual goals and expectations to ensure direct reports understand them responsibilities
• Responsible for managing the performance of staff, including providing input into salaries, bonuses as well as nominations for promotion.
• Promotes a positive and professional work environment that attracts and retains the best talent and delivers services that exceed customer expectations.
• May conduct assessment visits with staff as required by SOPs

Responsible for the management of resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual expectations by:

• Reviewing project tasks and timelines and assigning team members
  • Determines level and type of employee resources to meet corporate/client/project objectives
  • Schedules and reviews project tasks, provides leadership in the delivery of services to clients
  • Provides guidance/insight on aspects of clinical operations, as well as contingency planning, to accommodate projects while identifying potential impacts to the budget
• Leading Clinical Operations employees in the delivery of services to clients
• Ensuring staff fulfill their responsibilities in accordance with PRA’s policies, procedures, SOPs, ICH-GCPs, and other relevant regulatory requirements
• Liaising with other functional managers to ensure consistency within the company
• Maintaining utilization of all Clinical Operations employees within department goals

Provides leadership and implement Clinical Operations services and productivity improvements to ensure optimal utilization of billable staff by:

• Performing metric collection and data analysis to support PRA’s continuous improvement in policies, procedures, and business process
• Identifying and implementing process improvements through review of clinical operations SOPs, processes; recommending improvement plans to senior management.
• Leading task forces to implement process improvement initiatives
• Building teamwork and improving process and productivity by working within and across functional areas

Be a point of escalation (internal) for resolution of issues and conflicts.

Evaluates compliance of assigned Clinical Operations employees with PRA systems and processes

Provides support with proposal development and participates in client presentations and/or bid defense meetings, as required

What do you need to have?

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution, required.
• Advanced degree, or its international equivalent, preferred.
• Substantial experience using computerized information systems including experience with PC- Windows, word processing, and electronic spreadsheets, required.
• Substantial clinical trials development experience is, required
• Appropriate direct line management experience of Clinical operations staff; Experience supervising or managing professional staff in a clinical research environment, required
• Thorough knowledge of ICH and local regulatory authority regulations regarding drug research and development, required.
• Read, write, and speak fluent English
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

Why 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.

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.

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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.