Home Health Study Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

About the role

The Study Manager’s primary responsibility is to coordinate and manage all contracted services in assigned studies, providing quality service, and exceeding the expectations of our customers. The Study Manager manages the key relationships and communication among all internal and external stakeholders involved in a study, keeping all stakeholders informed in a timely and professional manner about the progress and key events with the study. The Study Manager is expected to accurately identify issues and creatively resolve problems while correcting processes as needed. This role is with Accellacare, part of ICON's clinical research network, where you’ll play a key role in transforming the clinical trial experience for patients and sponsors alike.

Location: Eastern or Central Time Zone - United States (Remote)

Responsibilities

• Coordinate, administer, and document all study management activities while maintaining and adhering to study project plans and timelines
• Train assigned staff (including subcontracted resources) and ensure staff is providing quality service
• Provide support and guidance for all resources, including routine teleconferences to review progress to timelines, issue management, and information sharing
• Contact necessary staff to ensure tasks are scheduled and have occurred per the required timelines
• Review study documentation to ensure completeness, accuracy and timeliness, and seek or correct documentation, as needed
• Ensure study information is updated and reports are reviewed and provided to the appropriate stakeholders according to expected timelines
• Solicit information to support inquiries from all stakeholders
• Support all internal and external team members in their efforts to support the study
• Participate in and lead study team reviews
• Act as the liaison between the sponsor, CRO, investigative site staff, laboratory, pharmacy and other internal and external personnel as the study requires
• Represent department effectively and professionally in project calls, webinars, teleconferences, and meetings
• Comply with ICH/GCP, IATA, HIPAA, and other appropriate regulations, policies and procedures
• Ensure overall study deliverables and that contracted study visits are completed on schedule, documentation is timely, complete, and accurate, and lab samples are evaluable

Requirements

• 2+ years of experience as a Clinical Research Coordinator, Clinical Research Associate, or similar clinical research role coordinating study startup, operational activities, and study closeout processes
• Exceptional attention to detail and organizational skills, with the ability to effectively manage multiple priorities and complex study activities concurrently
• Strong problem-solving skills with the ability to quickly assess situations, identify solutions, and resolve operational challenges
• Laboratory knowledge (preferred)
• Bachelor's degree, preferably in a life sciences, healthcare, or related field

Benefits

Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others