Opportunities at ICON plc

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.
• Represent Clinical Operations at Sponsor and internal audits.

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 roleKnowledge 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

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As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.

The Role

• To review and negotiate clinical site investigator contracts and budgets.
• Stay connected with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related documents
• Prepare and coordinate preparation of contractual documents and correspondence
• Facilitate the indemnification process between the study sponsor and the site.
• Function as the internal consultant on study budgets (investigator payments, develop and update training documentation and conduct group training as necessary, mentor and train new and junior personnel in the SSU department, and act as consultant on the Investigator Contract and Budget development process from origination through execution).

What you need

• A bachelor's degree in Paralegal Studies, Juris Doctor (law) degree, or related experience is preferred
• SSU experience is desirable but not required.
• Experience in a clinical research environment with specific experience in study contracts review and budget negotiation or in related field such as where contract or legal document review is a primary part of you role.