Clinical Study Associate Manager

About the role

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.

Responsibilities

• Contributes to risk assessment and helps identify risk mitigation strategies
• Serves as a point of contact for regional study activities
• 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
• Contributes to development of and oversees implementation of recruitment and retention strategies
• Makes sure recruitment and retention goals are met
• Makes sure progress for site activation and monitoring visits are monitored
• 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
• Ensures 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

Requirements

• Bachelors Degree and 4+ years of relevant industry experience
• Excellent communication and interpersonal skills; ability to build relationships internally and externally
• 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

Qualifications

• Must be located near Warren, NJ, Armonk, NY or Cambridge, MA and willing to report to an office 3 days per week

Skills

• Strong organizational and project management skills
• Ability to manage multiple projects simultaneously
• Excellent communication and interpersonal skills
• Attention to detail
• Technical proficiency in trial management systems and MS applications

Benefits

At ICON, we offer a range of benefits to support your well-being and work-life balance. These include:

• Variety of 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 for the future
• Global Employee Assistance Programme (EAP) 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
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Pay

Commensurate with experience

Schedule

Full-time, 3 days per week in an office location near Warren, NJ, Armonk, NY or Cambridge, MA