Manager, Quality Assurance, Clinical Trials

Job Summary:

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.

Essential Responsibilities:

+ 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).

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