Senior Manager Clinical Operations

Senior Manager Clinical Operations Overview

• The Senior Manager Clinical Operations oversees global clinical trials, ensuring adherence to protocols, timelines, and budgets.
• Leads cross-functional teams for clinical study delivery and provides operational strategic direction.
• Manages study documentation, systems setup, and vendor engagement for seamless trial execution.
• Ensures compliance with ICH/GCP standards and internal SOPs across all study phases.
• Develops and implements patient recruitment and retention strategies to meet study goals.
• Provides leadership in risk assessment and mitigation strategies to ensure study success.
• Oversees study drug forecasting, accountability, and reconciliation processes.
• Manages study close-out activities, including database lock and vendor contract reconciliation.
• Supports professional development and compliance training for Clinical Trial Management staff.

Senior Manager Clinical Operations Key Responsibilities & Duties

• Lead cross-functional teams to ensure successful clinical study delivery and execution.
• Develop and oversee study-specific documentation, including CRFs, monitoring plans, and data management plans.
• Manage study systems setup and maintenance, including CTMS and TMF.
• Identify outsourcing needs and oversee vendor engagement and management.
• Monitor site activation, patient recruitment, and data entry progress, addressing deviations promptly.
• Provide input into study budget and timeline development and management.
• Lead risk assessment and mitigation strategies at the study level.
• Supervise Clinical Trial Management staff, ensuring compliance and professional development.
• Oversee study close-out activities, including database lock and drug accountability.

Senior Manager Clinical Operations Job Requirements

• Bachelor of Science (BS) degree with a minimum of 8 years of clinical trial experience.
• Proven expertise in global clinical trial operations and protocol development.
• Advanced technical proficiency in trial management systems and MS applications.
• Experience in line management, coaching, and mentoring clinical operations staff.
• Strong interpersonal and leadership skills with the ability to influence and negotiate.
• Proactive and self-disciplined with effective time management and prioritization skills.
• Knowledge of ICH/GCP standards and compliance requirements for clinical trials.
• Ability to manage study budgets, timelines, and risk mitigation strategies effectively.
• Experience with patient recruitment and retention strategies in clinical trials.