Duties and Responsibilities: Document the duties and responsibilities that account for at least five percent of the incumbent’s time or are critical to the successful performance of the job. List duties and responsibilities in the order of criticality or those that require the most time.

Duties include but are not limited to:

 Develop and maintain effective relationships with Sponsors, company operational leaders, operational colleagues supporting research activities and all other colleagues, as necessary

 Oversight of controlled documents and training management processes in eQMS via SmartSolve

 Provide guidance to research operations on the interpretation of ICH-GCP, local and federal regulatory requirements as related to the conduct of clinical research

 Prioritize and escalate “Critical” and “Major” quality issues, identified procedural gaps and/or other areas of deficiency. Report deficiencies to Executive and Physician leadership, where appropriate

 Manage and facilitate all external Sponsor, IRB, or other audits of Innovations, including but not limited to preparation, hosting, responding and follow-up of those deliverables resulting from the sponsor’s audits

 Manage and facilitate any regulatory agency inspection of Innovations, including but not limited to preparation, hosting, triaging, responding and continued follow-up of those deliverables resulting from the regulatory inspection

 Lead or participate in the development and/ or process improvements to standards, policies, procedures, and work instructions to support the Quality Management System and company functional group processes

 May conduct internal, site and vendor audits, as assigned, including planning, executing, reporting, follow-up, and tracking of action items resulting from those audits to completion

 Provide guidance and support for non-conformance resolution including root-cause analysis, corrective and preventive actions 

 Develop, manage, and maintain quality management plans, where appropriate

 Through routine trending and metric reporting, identify systemic areas of non-compliance and process deficiencies. Propose and facilitate process improvements in areas of deficiency

 Develop, modify, and utilize tools to track and trend compliance issues for value added feedback to the

business line

 Develop and track timelines to ensure timely and appropriate corrective and preventive actions in areas

of deficiency

 Maintain records to support the Quality Management System and any supporting documentation

 Educate, train, and mentor colleagues in quality improvement methods

 May attend training courses, relevant conferences or association meetings to continue to gain industry trends and insight, and share that knowledge with internal colleagues, where necessary

 May participate or lead divisional or departmental process improvement efforts

 Perform related work as required