Clinical Operations Manager

Manager, Clinical Operations (COM)

Location: Home Based - United States

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

As a Clinical Operations Manager at ICON, you'll work with coordination, execution, control and completion of Clinical Operations. Ensure delivery and development of the Clinical Operations team against key metrics. Work with Leadership to develop and grow capabilities, productivity, and quality. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.

The role

• Provide direction and accountability for the operational teams and their delivery at regional and site level.
• Resourcing, line management, training, functional delivery and input on discussions around quality and operational delivery measurements within the Clinical Operations group
• Conduct regular discussions with direct reports and lead team meetings at regional and manager team level.
• Assist with training for CRA Managers and Associates as required.
• Contact for region in regard to operational questions and escalations.
• Work with Director/Senior Director and/or VP Clinical Operations to communicate all critical issues, business growth opportunities, developing key relationships as well as providing input regarding budgeting discussions to drive productivity and quality within the region.
• Drive overall delivery at site and regional level, through your operational team to drive execution of service, client satisfaction, quality and efficiencies.
• Representing Clinical Operations at Sponsor and internal audits.
• Providing feedback on the development and implementation of formal CRA training tools and presentations.
• Implementing agreed corrective actions and/or further training as required.
• Conducting timely CRA performance reviews and appraisals by acquiring feedback on CRA performance from Project Managers and others as required. Ensure that clear goals and objectives are set.
• Making recommendations for CRA promotions.
• Conducting regular CRA group meetings to provide timely and relevant updates.
• Assisting with continuous review of current processes and implementation of agreed process improvements in collaboration with other departments.
• Interviewing, evaluating and selecting new CRA hires.
• Ensuring induction and orientation for newly hired CRAs occurs.
• Ensuring CRAs are meeting performance objectives and take appropriate remedial actions as required
• Ensuring that CVs for assigned CRAs are updated as required and skill set / experience is maintained in Planview.
• Participating in business development activities, as appropriate

What you need

• Bachelor's degree
• Minimum 6 years Clinical Research experience that includes a minimum 4 years relevant experience as a Senior CRA or Principal CRA (in a Lead CRA role), or at least 2 years as a Project Manager, CRA Manager or equivalent job role
• Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
• Excellent management skills, developed with a collaborative approach to driving performance and success in a global environment
• Direct experience managing Clinical Research Associates is preferred

Why join us?

Ongoing development is vital to us, and as a COM you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin