About the job
Senior Clinical Trial Manager (Sr. CTM)
Responsibilities
- Collaborate with Clinical Study Management to lead and supervise the comprehensive management of international clinical trials, ensuring the delivery of high-quality study data within agreed timelines and budgets.
- Design and implement operational strategies for the effective management of oncology clinical trials.
- Work closely with multidisciplinary teams, including data management, clinical scientists, regulatory affairs, and investigators, to drive operational excellence and expedite the delivery of high-quality data.
- Oversee all trial start-up processes, partnering with Clinical Operations functions (Site Engagement & Monitoring Excellence, and Supplier Relationship Management & Performance) to streamline site selection, conduct feasibility assessments, and prepare essential study documentation.
- Facilitate efficient study site initiation and training activities in collaboration with Clinical Operations to ensure compliance with study protocols, regulatory standards, and ICH-GCP guidelines.
- Establish and nurture strong relationships with investigators, study coordinators, and site personnel to enhance patient recruitment and retention.
- Continuously monitor and assess study progress, identifying potential risks, issues, and deviations, and implementing corrective actions to uphold study integrity and timelines.
- Ensure adherence to regulatory requirements, including ICH-GCP, FDA guidelines, and other applicable regulations throughout the trial lifecycle.
- As needed, collaborate with external vendors, including CROs, central laboratories, and imaging providers, to assure their effective contributions to the trial.