Clinical Trial Management Associate

Clinical Trial Management Associate Overview

• The Clinical Trial Management Associate will oversee clinical study delivery, collaborating with internal teams and external vendors to ensure successful execution.
• Contribute to a science-driven organization focused on developing life-changing medicines for patients worldwide.
• Support clinical trial planning and management, ensuring alignment with global study plans and timelines.
• Maintain study systems such as CTMS and TMF, ensuring compliance and readiness for audits.
• Engage with vendors for contracting and management, overseeing clinical supplies and drug accountability.
• Collaborate on recruitment and retention strategies, monitoring site activation and progress.
• Ensure data quality through regular reviews, addressing protocol deviations and compliance issues.
• Participate in study close-out activities, including database lock and reconciliation of vendor contracts.
• Mentor clinical trial management staff and contribute to the development of unmasked study tasks.

Clinical Trial Management Associate Key Responsibilities & Duties

• Lead planning and management of clinical studies within assigned regions, ensuring alignment with global plans.
• Contribute to risk assessment and mitigation strategies, supporting feasibility assessments for study regions.
• Develop and review study-specific documentation, including CRFs, monitoring plans, and informed consents.
• Maintain study systems, prepare investigator meetings, and oversee vendor engagement and management.
• Provide regular status reports to stakeholders, supporting recruitment and retention strategies.
• Monitor data quality, addressing deviations and compliance issues, escalating concerns as needed.
• Ensure clinical study deliverables are met within planned timelines and budgets, escalating issues as necessary.
• Support audit readiness throughout the study lifecycle, contributing to CAPAs and inspection activities.
• Manage study close-out activities, including database lock and reconciliation of study budgets and drug accountability.

Clinical Trial Management Associate Job Requirements

• Bachelor’s degree in Science or related field with 4+ years of relevant industry experience.
• Proficiency in trial management systems and MS applications, including Project, PowerPoint, Word, Excel, and TMF.
• Knowledge of ICH/GCP guidelines and regulatory directives, with experience in clinical trial operations.
• Strong data-driven approach to problem-solving and attention to detail in study activities.
• Experience in vendor management and familiarity with medical terminology.
• Ability to manage budgets and contribute to financial aspects of clinical studies.
• Effective communication skills for collaboration with internal teams and external vendors.
• Capability to mentor junior staff and manage unmasked study tasks.
• Flexibility to work in a hybrid model, contributing to a fast-paced, innovative environment.