CSM

ICON plc is a global leader in healthcare intelligence and clinical research, partnering with pharmaceutical, biotechnology, medical device, and public health organizations to advance clinical trials. We focus on improving patient outcomes by bringing life-changing therapies to market.

As a Clinical Site Manager, you will be dedicated to one of our global pharmaceutical clients, where ICON shares a culture of innovation, flexibility, and a common vision of bringing life-improving drugs to market. Leading by example, you will set a standard of excellence and enjoy a challenging career in our exclusive programs.

We are seeking a Clinical Site Manager for this role with the following qualifications:

• Home-Based position
• Oncology Focus
• 50% Site Engagement and 50% Monitoring
• National Travel required
• Immediate Availability

What You Will Be Doing:

Site Engagement Deliverables:

• Develop, communicate, and execute a Site Engagement Strategy/Plan, working closely with the Clinical Team and internal stakeholders throughout the clinical trial lifecycle.
• Support the clinical team in coordinating and executing site engagement activities, understanding the competitive landscape, identifying trial challenges, and using motivational tactics to ensure timely trial delivery.
• Engage, evaluate, and develop a global network of high-performing sites through coordinated and consistent interactions, leveraging multiple communication channels to increase their interest in partnering with the sponsor.
• Build and maintain relationships with site engagement organizations, identify high-performing sites and key opinion leaders, and contribute to forums, boards, and discussions.
• Interact with and train new investigators on sponsor clinical trials.

Monitoring Deliverables:

• Responsible for all site visits, including feasibility, site selection, and monitoring.
• Serve as the primary contact for sites regarding study-related issues.
• Lead early engagement with Key Opinion Leaders, sites, and patient organizations, and serve as the main point of contact throughout the study.
• Attend key therapeutic trainings/meetings and industry events.
• Assist the Clinical Project Manager (CPM) in study management, including:
  • Vendor management
  • Training
  • Logistics
  • Site selection
  • Study tracking
  • Oversight of eTMF
• Maintain close cooperation with Clinical Project Managers and study team members to ensure accurate reporting on clinical trial status at sites.
• Ensure effective engagement and communication with internal stakeholders regarding site visits and related activities.
• Contribute to the development of study documents, such as Case Report Forms, informed consent/participant information, study protocols, and presentations for Investigator Meetings.
• Prepare and review monitoring tools, including monitoring manuals.
• Support CRO/vendor selection and provide input on monitoring contract specifications.
• Review and approve site regulatory packages and responses to questions from Regulatory Authorities and IRBs/ECs.
• Contribute to clinical program updates, including safety updates, Investigator’s Brochure, and query resolutions.
• Train internal and CRO personnel on trial-specific monitoring requirements.
• Track monitoring activities, including regulatory package status, visit reports, and data collection timelines.
• Conduct co-monitoring visits with internal or CRO personnel to ensure quality, initiating corrective actions when needed.
• Utilize applicable Decentralized Clinical Trial methods.
• Share insights, innovation opportunities, and patient needs with internal teams and the Technology Transformation Implementation Teams.