Lead Site Activation Manager - Home-Based (US)

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.

Overview:

The Lead Site Activation Manager (Lead SAM) engages cross‐functionally with the Study Team to ensure each trial is activated according to best practices, ICH GCPs, and sponsor SOPs. The Lead SAM provides oversight of the Site Activation Managers (SAMs) for trial activation activities ensuring timelines are achieved within time, cost and quality parameters. This role shares trial activation information for study planning discussions and identifies risks, mitigations, and escalates appropriately.

• Responsible for activation of all study sites to meet project timelines
• Responsible for oversight of SAMs assigned to trial
• Interaction with other departments to communicate and negotiate timelines , including Clinical Budget Management and Regulatory Affairs
• Facilitate Informed Consent Form review and negotiation process for study, country and site templates

• Effectively communicates project risk and mitigation strategies to Study Team members
• Lead problem solving and resolution efforts to include management of risk, contingencies, and issues
• Identify quality issues within the study to implement appropriate corrective action plans.
• Facilitate generation and finalization of documents and applicable translations for global regulatory and EC submissions according to applicable SOPs and WIs
• Ensures data integrity by overseeing data cleaning efforts for internal information systems, setting standards for data entry and maintenance
• Mentors and coaches junior staff as assigned
• Performs other duties as assigned

• Organizational skills to independently manage all aspects of study activation and meet project deadlines

• Experience and expertise in managing high‐volume clinical study start‐up activities

• Strong understanding of global study start‐up requirements and activities, including Informed Consent Form requirements

• Excellent communication (written and verbal) skills to be able to interact with internal groups (Legal, Medical Monitors, Regulatory Affairs, etc.) as well as external groups (e.g. Investigators and CRO, if applicable)

• Able to proactively identify project opportunities, challenges, risks and implement appropriate actions with minimal supervision

• Ability to work in a matrix, cross‐functional team

• Demonstrates thorough knowledge and understanding of key regulatory authorities and regulatory requirements, ICH Guidelines, and GCP’s governing the start‐up of clinical trials

• B.S. or Advanced Degree (or equivalent degree/experience in the opinion of the Hiring Manager) and minimum of 10 years of relevant work experience

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.