Sr. Manager, Trial Deliver Leader

Salary

Core Qualifications

Key Responsibilities

• •Lead the Cross Functional Trial Team (CFTT) to influence and execute delivery of the operational plan and for end-to-end trial execution.
• •Accountable for overall trial delivery, budget, timelines, quality, and milestones (e.g., support DBL / CSR / TLR planning and scope, define protocol deviations and resolution pathways).
• •Proactively ensure that trial deliverables and milestones are met.
• •Identify risks and ensure mitigation and contingencies are being initiated and followed through.
• •Ensure trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes.
• •Accountable for identifying risks in study conduct, developing mitigation plans and escalating concerns to the CT or CDT.
• •Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits.
• •Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight.
• •Participate in process improvement activities at a trial, compound & cross-DU level, as needed.
• •Lead and ensure inspection readiness for program through risk identification and readiness review.
• •Provide leadership during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.
• •Mentor & support onboarding of new team members, particularly those in Trial Management.
• •Foster employee engagement, inclusion, and Credo Behaviors.