Senior Manager, Clinical Operations

Manager, Clinical Operations is accountable for the end-to-end clinical trial delivery, providing operational leadership and oversight of cross-functional deliverables and leading a cross functional trial team to build and deliver the trial operational plan. Responsible for leading the Cross functional trial team to influence and execute delivery of the operational plan and for end-to-end trial execution. Ensure trial Is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes 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 and department level as needed Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure. Support and provide input into internal governance presentations & updates Ability to travel approximately 10% but flexibility to go over or below as per business need). BS/ BA degree is required. Minimum 7+ years of clinical research experience gained with a CRO, Biotech or Pharmaceutical Company working on Phase 1-4 global clinical trials. 3-5 years leading end to end global clinical trials with experience in conducting Phase 3 registrational trials Experience leading global trials outsourced to a CRO and ability to manage all aspects of execution of a clinical trial Excellent decision-making, analytical and financial management skills are essential to this position Excellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision Experience in leading without authority and in multifunctional matrixed and global environments Experience mentoring/ coaching others Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability. Strong project planning/ management, communication (written and verbal) and presentation skills Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.