Associate Director Study Management

Develop and execute trial operational strategies for assigned studies and contribute to broader program-level planning in partnership with the Director and cross-functional stakeholders. Ensure appropriate timely and quality oversight, and appropriately escalate issues to the Director, Quality and functional leadership. Build knowledgeable and skilled team with competencies and capabilities to successfully set up and deliver clinical trials Ensure staff training on procedures and systems associated with their roles Develop a team that consistently achieves strong results through nurturing individual growth, effectively managing performance, and providing guidance Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits Ability to effectively communicate the operational strategy, and defend the operational plan and costs associated to CTWG, CDST, Director, leadership and at governance meetings as appropriate. Ability to travel (expected annual average of 10% but flexibility to go over or below this as required). BS/ BA degree is required. Minimum 8+ years of clinical research experience gained with a CRO, Biotech or Pharmaceutical Company working on Phase 1-4 global clinical trials, at least 3 of which leading end to end global clinical trials with experience in conducting Phase 3 registrational trials. Minimum 2-5 years of direct people leadership experience, including coaching, performance management, and development of clinical operations professionals. Experience in and knowledge of the pharmaceutical development process Excellent decision-making, analytical and strong financial management skills are essential to this position Ability to manage all aspects of execution of a clinical trial Must possess 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 Strong project planning/ management, communication (written and verbal) and presentation skills Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability. Apply project management best practices to programs. Experience in novel clinical drug development. Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.