Clinical Study Associate Manager

ICON plc • Warren Township, NJ

1d • $62,376 - $77,970 • Hybrid

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Requirements

• Bachelors Degree and 4+ years of relevant industry experience.
• Excellent communication and interpersonal skills; ability to build relationships internally and externally
• A data driven approach to executing and problem solving
• Attention to details for the ability to deliver on specific study activities
• Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Budget awareness with the ability to participate in various aspects of budget management
• Familiarity with medical terms
• Vendor management experience
• Experience in clinical trial operations including experience developing key study documents
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Must be located near Warren, NJ, Armonk, NY or Cambridge, MA and willing to report to an office 3 days per week
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Responsibilities

• May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with the global study plans and may contribute to global planning and management of the study
• Contributes to risk assessment and helps identify risk mitigation strategies
• Supports feasibility assessment to select relevant regions and countries
• Oversees and provides input to the development of study specific documentation including but not limited to: case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc.
• Reviews site level informed consents and other patient-facing study start-up materials
• Oversees setting up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF)
• Contributes to investigator meeting preparation and execution
• Oversees engagement, contracting and management of required vendors for the study
• Oversees and provides input to study drug and clinical supplies forecasting, drug accountability and drug reconciliation
• Provides regular status reports to stakeholders as requested by the Clinical Study Lead
• Contributes to development of and oversees implementation of recruitment and retention strategies
• Monitors recruitment and retention
• Monitors progress for site activation and monitoring visits
• Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites
• Escalates data flow and data quality issues to Clinical Study Lead
• Oversees the execution of the specific clinical study deliverables against planned timelines
• Escalates issues related to timelines or budget to Clinical Study Lead
• Supports accurate budget management and scope changes
• Contributes to clinical project audit and inspection readiness throughout the study lifecycle
• Supports internal and external inspection activities and contributes to CAPAs as required
• Manages aspects of study close-out activities including but not limited to database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level