Senior Clinical Trial Manager

Description

• Activities ensuring high quality deliverables are within budget and timelines.
• Support cross-functional Study Team within Clinical Operations with minimal oversight from the Sr. CTM and/or CPL.
• Clinical Operations deliverables to achieve study objectives and milestones within timelines and budget.
• Responsible for vendor selection and management including CRO, IVRS, central lab and imaging vendor.
• Provide input to the study budget and is responsible for managing assigned vendor budget(s).
• Under the leadership of the Sr. CTM, takes responsibility for agreed operational aspects (e.g., vendor management, drug supply management).
• Identify and track timelines, milestones, critical study activities, issues and budget and provide regular updates to the Study Team and CPL as appropriate.
• Partner with CPL to develop and/or present at project teams and management review bodies.
• Obtaining agreement on project timelines, budgets, study objectives, and goals.
• Ensure relevant functional groups provide input to and participate in developing and finalizing Study Team level documents and meet Study Team level deliverables within timelines.
• This is not an exhustive list of responsibilities.

• Experienced in clinical trial management.
• Extensive experience in Oncology required.
• Experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, conduct and monitoring of clinical studies.
• Familiar with global trial requirements.
• 5+ years direct industry study management experience in clinical and drug development
• Bachelors degree or equivalent undergraduate degree (scientific or healthcare discipline preferred)
• Working knowledge of international regulatory and ICH GCP guidelines