Manager, Quality Assurance, Clinical Trials

In addition to the responsibilities listed below, this position is also responsible for overseeing quality assurance monitoring to ensure compliance in clinical trials (e.g., addressing monitoring requests, identifying deviations/violations of protocol, recommending remedies); managing the consultation of study workflows to improve compliance outcomes; leading auditing activities; managing the education of others on regulations (Good Clinical Practice, Food and Drug Administration regulations, HIPAA) to ensure compliance; training team to support and implement quality management system initiatives including compliance quality control; guiding team members to collaborate with internal and external audit agencies during auditing process; leading the development and implementation of internal and external audit protocols; reviewing analyses of monitoring analysis results; managing initial and ongoing study risk assessments; and reviewing auditing and quality summaries and reports.

• Provides developmental opportunities for others; builds collaborative, cross-functional relationships. Solicits and acts on performance feedback; works closely with employees to set goals and provide open feedback and coaching to drive performance improvement. Pursues professional growth; develops and provides training and development to talent for growth opportunities; supports execution of performance management guidelines and expectations. Leads, adapts, implements, and stays up to date with organizational change, challenges, feedback, best practices, processes, and industry trends. Fosters open dialogue amongst team members, engages, motivates, and promotes collaboration within and across teams. Delegates tasks and decisions as appropriate; provides appropriate support, guidance, and scope; encourages development and consideration of options in decision making.


• Manages designated work unit or team by translating business plans into tactical action items; oversees the completion of work assignments and identifies opportunities for improvement; ensures all policies and procedures are followed. Aligns team efforts; builds accountability for and measuring progress in achieving results; determines and ensures processes and methodologies are implemented; resolves escalated issues as appropriate; sets standards and measures progress. Fosters the development of work plans to meet business priorities and deadlines; obtains and distributes resources. Removes obstacles that impact performance; identifies and addresses improvement opportunities; guides performance and develops contingency plans accordingly; influences teams to execute in alignment with operational objectives.


• Manages budgeting and financing by: guiding the review and drafting of contract proposals within and across units; monitoring and managing budgets for internally and externally funded projects; and monitoring contracts and subcontracts.


• Coordinates and manages clinical research by: guiding and coordinating team in the preparation and submission of a portfolio of research proposals as applicable; guiding and coordinating team in the collection, management, analyses, and interpretation of clinical trials data; orchestrating internal resources needed to provide consultation on implementing clinical trials for staff; influencing the development and implementation of policies and procedures for developing research protocols and other processes of clinical trials; overseeing the preparation, submission, and/or compilation of study documentation sent to regulatory bodies (e.g., IRB) for review and approval prior to implementation; may also be responsible for training others to execute clinical trial activities (e.g., informed consent process, lab support and processing, pharmaceutical documentation data, sample processing, adverse event assessment process); and may be involved in training others to support research lab operations(e.g., biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens).


• Guides research compliance by: leveraging advanced knowledge of clinical trials while planning the effective, long-term design of clinical trial applications to ensure compliance with all applicable federal, state, and local regulations and KP policies and procedures within unit or team; developing guidance for identifying and resolving compliance and/or quality issues and developing corrective action plans; developing and socializing updates for compliance-monitoring/audit systems and documentation; leading the implementation of new or updated research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data; driving the implementation of research protocols, procedures and guidance to ensure confidentiality, privacy, and security of clinical research data within unit; and overseeing and advising team members who are providing guidance and partnering with investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines.


• Manages internal and external working relationships by: developing effective team building with research stakeholders and investigators within and across unit; serving as a major point of within-unit contact for key contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers; and developing materials and guiding the education of staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions.


• Ensures documentation of clinical research files by: coordinating the teams progress on the timeliness, accuracy, and completion of documentation of all research activities (e.g., consent forms, reports, tracking forms); driving the application of strategies to determine the best course for developing quality control and/or assurance measures and providing feedback to research staff and management; assessing volunteers and/or patients for eligibility to participate in Clinical Trials, defining issues and developing solutions for resolving complex escalations when necessary; and managing teams efforts while monitoring and auditing Clinical Trials across sites and presenting findings to KP leadership.