Job DescriptionABOUT US Smith & Nephew supports healthcare professionals inmore than 100 countriesin their daily efforts to improve the lives of their patients. We do this by taking apioneering approachto the design of ouradvanced medical products and services, by securing wider access to our diverse technologies for more customers globally, and by enabling better outcomes for patients and healthcare systems. We have leadership positions in: Orthopaedics Reconstruction - joint replacement systems for knees, hips and shoulders Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds Sports Medicine - minimally invasive surgery of the joint Trauma & Extremities - products that help repair broken bones We have around15,000 employeesaround the world. Annual sales in 2016 were more than $4.6 billion. We are a constituent of the UK's FTSE100 and our shares aretraded on the London Stock Exchangeand throughAmerican Depository Receipts on the New York Stock Exchange(LSE: SN, NYSE: SNN) SUMMARY The Director, Global Quality, Training & Monitoring is responsible for ensuring Global Clinical Operations is executing deliverables according to approved SOPs and quality standards for all Smith & Nephew Initiated Studies (SNIS). This position has professional responsibilities for ensuring training is appropriately completed and documented, the quality of the work is performed is within the standards set by CSMA leadership. This position is also responsible for all Process Improvement activities within GCO. This position is also responsible for all Monitoring activities conducted by S&N staff or by outsourced staff. Ensuring quality oversight through review of Key Performance Indicators (KPIs). Responsible for advising study teams on key monitoring concepts and strategies during protocol and Clinical Monitoring Plan development. Essential Functions Establish quality standards, training and key performance Indicators (KPIs) in which all members of GCO should operate within. Develop and deliver any required and necessary training to ensure GCO staff are meeting the quality standards expected. Oversee all Process Improvement activities within GCO and ensure gaps are identified and processes are improved to ensure the flawless execution of all Clinical Trials. Interpret company and regulatory guidance to ensure Global Clinical Operations compliance; train cross department staff as needed; may implement corrective and preventive measures. Serve as Subject Matter Expert in Global Clinical Operations clinical process improvement projects. Oversee and optimize all monitoring vendors and ensure appropriate utilization globally. Serve in leadership capacity in reviewing monthly cost center reports and spend; function as part of the Global Clinical Operations' leadership team. Ensure oversight of S&N monitor and contractor site assignments in order to support the financial/contractual planning, organization and operation of global clinical studies. Report on performance to plan; remove obstacles that impede workflow. Provide leadership and strategic direction to the monitoring team in order to achieve operational objectives through effective coaching, mentoring and utilization of resources. Oversee the monitoring program for studies that are both insourced and outsourced to ensure adequate oversight of all SNIS. Ensure on-site quality visits are conducted to evaluate monitor performance (compliance with study protocols, regulatory requirements, and Smith & Nephew SOPs). Train CRA Managers and Clinical Study Managers to attend on-site quality visits, as necessary. Provide escalation, as appropriate, to S&N VP, Global Clinical Operations when issues of monitor compliance and/or performance issues with CRO partner are identified. Identify and implement monitor/CRO retraining and/or CAPAs.