Senior Associate Study Manager

IRE • Cary, NC

4d

About The Position

Senior Associate 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 What you will be doing Work with the clinical trial management staff to support the execution and monitoring of clinical studies and trial deliverables. Participate in study planning and set-up activities including vendor management, project management, and coordination of study and implementation plans. Contribute to and support with the preparation, writing and review of study related documents including but not limited to, clinical protocols, consent forms, study guides, monitoring plans, e(CRF)s, subject information sheets, clinical study report, regulatory submissions and publications. Quality Check study protocols and ICFs Coordinate the activities associated with site start-up and overall trial management Assist in identification and evaluation of clinical trial investigators and Phase 1 clinical research units. Author monitoring plan, IPD list, IPIM Contribute to the study level forecast of IP and support the creation of DSP and JCP Provide input into the development of CRFs and SAP Contribute to, or coordinate preparation and conduct of site initiations, monitors workshops (as applicable) and investigator meetings (as applicable) Assists in preparing and managing Study Budgets and timelines Coordinate study level investigational product arrangements and study start-up and management activities. Serve as one of the first points of contact within Early Development for study-related issues Support vendor relationships Perform protocol-related site management activities Assists for ensuring all site and study team members are trained on the conduct of the study and they understand the study timelines and deliverables. Coordinate activities as needed between study team members.

Requirements

• Knowledgeable in International Conference on Harmonization (ICH), Good Clinical Practice (GCP), FDA regulations/guidelines, and applicable international regulatory standards
• Experienced in interactions with external vendors (e.g., CROs, contract labs)
• Skilled in developing prospective site-selection criteria
• Well-versed in the drug development process and related procedures
• Organized and effective in planning and communication
• Proficient in project planning with oversight of study deliverables, budgets, and timelines
• Able to apply scientific and clinical knowledge to conceptualize study designs
• Adept at anticipating and resolving problems proactively
• Clear and concise in writing and presenting on scientific and clinical topics
• Collaborative, with a proven ability to lead in team and matrix environments
• Educated with a Master’s degree, or a Bachelor’s/RN and 3+ years of experience, or an Associate’s and 6+ years, or a High School diploma and 10+ years in a life sciences or medically related field

Responsibilities

• Work with the clinical trial management staff to support the execution and monitoring of clinical studies and trial deliverables.
• Participate in study planning and set-up activities including vendor management, project management, and coordination of study and implementation plans.
• Contribute to and support with the preparation, writing and review of study related documents including but not limited to, clinical protocols, consent forms, study guides, monitoring plans, e(CRF)s, subject information sheets, clinical study report, regulatory submissions and publications.
• Quality Check study protocols and ICFs
• Coordinate the activities associated with site start-up and overall trial management
• Assist in identification and evaluation of clinical trial investigators and Phase 1 clinical research units.
• Author monitoring plan, IPD list, IPIM
• Contribute to the study level forecast of IP and support the creation of DSP and JCP
• Provide input into the development of CRFs and SAP
• Contribute to, or coordinate preparation and conduct of site initiations, monitors workshops (as applicable) and investigator meetings (as applicable)
• Assists in preparing and managing Study Budgets and timelines
• Coordinate study level investigational product arrangements and study start-up and management activities.
• Serve as one of the first points of contact within Early Development for study-related issues
• Support vendor relationships
• Perform protocol-related site management activities
• Assists for ensuring all site and study team members are trained on the conduct of the study and they understand the study timelines and deliverables.
• Coordinate activities as needed between study team members.

Benefits

• In addition to your competitive salary, ICON offers a range of additional 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.
• Our benefits examples include:
• 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees