Clinical Study Associate Manager

Overview

As a Clinical Study Associate Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• 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
• May be responsible for mentoring clinical trial management staff
• May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring
• May require up to 20% travel
• Location Eastern timezone

Qualifications

You are:

 

• 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

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. 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 maximise 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 ind