Job Description

Clinical Study Associate Manager

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.

What You Will Do:

• 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

Your Profile:

• 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.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here

Salary Range

$62,376.00-$77,970.00

Are you a current ICON Employee? Please click here to apply