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.