Sr. Analyst, IT - Compliance & Quality , DCRI TDS - Military Veterans

at Duke University and Duke University Health System

Durham, North Carolina

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

 

Position Summary

As part of the Compliance, Quality & Operational Excellence group, the Sr. Analyst, IT - Compliance & Quality will represent the department for organization-wide quality and operational excellence initiatives. This role will manage quality improvements efforts for the department, serve as the departmental liaison for internal and external audits and surveys, and create, review and approve SDLC deliverables. The Sr. Analyst, IT - Compliance & Quality will function as communications liaison between Technology and Data Solutions (TDS) and Quality Assurance to anticipate, track, respond and help resolve quality incidents related to TDS operations. May participate in performance appraisals and hiring initiatives.
 

Position Responsibilities

  • Provides consulting on SOP development within the TDS department.
  • Leads risk assessment sessions related to the SDLC SOP within the TDS department.
  • Participates with Quality Managers to facilitate root cause analysis sessions to identify source of problems or non-conformance in TDS.
    Analyzes and propose best practices for implementing operational excellence initiatives.
  • Proactively identifies and facilitates opportunities to enhance the quality and cost-effectiveness of TDS services across the organization.
  • Communicates regularly with internal and external customers, in order to ensure the delivery of high quality systems and audit documentation.
  • Leads the team in regulatory audit / inspection readiness activities.
  • Serves as the primary TDS representative for qualification and system audits. (Data Management teams lead trial configuration audits.) Follows QARS SOPs for audit participation and CAPA management. Manages CAPA responses for TDS. Analyzes the findings and makes recommendation to stakeholders.
  • Creates and/or reviews Solution Development Life Cycle documentation for TDS projects.
  • Understands the role of DCRI TDS in the overall corporate strategy and planning, and set objectives that are aligned with this role.
  • Leads efforts to determine risk categorization.
  • Serves as a compliance and quality consultant to the TDS group and identifies gaps in core competencies and effectively uses strategies to build needed knowledge, skills, and abilities within the group.
  • Seeks and take advantage of opportunities to expand knowledge of DCRI operations beyond normal requirements or expectations.
  • Identifies and acts upon opportunities to improve communications at all levels and in all directions.
  • Facilitates cross-functional communication in order to identify compliance and quality gaps and resolve conflict in finding solutions for the gaps.
  • Solicits feedback, evaluates and monitors client or customer satisfaction to improve the quality of services.
  • Works with DCRI teams to improve validation processes and policies.
  • Creates and/or procures of training content for GXP.
  • Keeps abreast of current developments and emerging issues and risks both within the technology organization and the information technology industry, and apply gained knowledge to audit practices.
  • Accepts other duties as assigned.

 

 

Minimum Qualifications

 

Education and Experience

BA or BS in computer science / computer-related field, technical communication / documentation or quality field

  • Experience 8 or more years of audit, compliance and information system experience, or equivalent combination of education and experience.

 

Skills, Training and Certifications:

  • Experience in a clinical trials environment preferred
  • Demonstrate willingness to accept new or additional responsibility
  • Thorough understanding of drug development and clinical trial process
  • Thorough understanding of FDA Guidance on General Principals of Software Validation

 

 

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

 

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

 

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

 

Durham, North Carolina

As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.

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