ASSOC DIR, IT Compliance, Quality & Organizational Excellence


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ASSOC DIR, IT Compliance, Quality & Organizational Excellence
DCRI - Information Technology

Who We Are:
As the world's largest academic clinical research organization and part of the Duke University School of Medicine, the Duke Clinical Research Institute (DCRI) is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. We are dedicated to advancing clinical research by promoting innovation, education, scientifically designed studies, and operationally efficient clinical trial conduct.

The Associate Director, Compliance, Quality & Organizational Excellence will lead several teams responsible for all aspects of maintaining adherence to internal and external compliance requirements and improving the overall quality management standards for Technology & Data Solutions. This individual will be responsible for risk/scoping analysis, policy management, artifact collection, audit-readiness assessment, vendor management, product ownership, change management, solution validation/testing, training compliance and internal and external coordination for auditing. This person reports directly to the Executive Director, Technology & Data Solutions.

Primary Job Responsibilities
  • Oversee the deployment and maintenance of a proactive Compliance and Risk Assessment model for Technology & Data Solutions Research, define and implement process improvement initiatives supporting the Technology & Data Solutions organization
  • Oversee Technology & Data Solutions Leadership in managing the development, review, implementation, and improvement of Technology & Data Solutions policies, procedures and processes, ensuring compliance with relevant laws, regulations, and frameworks
  • As appropriate, lead the development of transformational SOPs and other procedural documents
  • Ensure adoption of Technology & Data Solutions policies, procedures, and controls
  • Manage key IT and security risk assessment and compliance programs for proactive risk management
  • Maintain the Technology & Data Solutions scorecard, facilitating the update and review of key metrics, as well as improvement planning as it relates to internal compliance programs
  • Develop and socialize appropriate metrics and dashboards and report on key activity and performance indicators concerning Technology & Data Solutions Governance, Risk and Compliance
  • Provide strategic compliance road maps and the overall Technology & Data Solutions strategy
  • Establish and maintain influential and coaching relationships with control and process owners to proactively assess business as well as aligned Technology & Data Solutions risks and develop risk mitigation
  • Establish and manage a Vendor Management Office (VMO) for identification, contracting and oversite of technical solution vendors Partner with and manage 3rd party vendors to ensure effective and auditable controls are in place, including evaluating Validation and Project documentation for compliance with general controls such as SLAs and BAAs
  • Establish the usage of a Contract Management system to proactively manage 3rd party vendors. Work to increase value and service levels from vendors
  • Manage the IT Disaster Recovery process including maintaining the procedure, establishing improvements based on learnings from exercises and ensuring that 3rd party vendors can meet / respond to our needs
  • Establish and manage standard processes for technical product ownership and lead a team of technical product owners (including license, security, roadmap and contract mgmt.) to support business processes and manage solution environments
  • Work with technical process teams to assess change readiness and project risk related to change
  • Develop measureable Technology & Data Solutions audit plans and policies, SOPs, and Technology & Data Solutions Controls
  • Work with company's internal & external auditors to ensure continued compliance with regulatory (GXP, HIPAA, etc.) requirements and internal control standards including tracking and follow-through of corrective actions are implemented
  • Drive the execution of multiple work streams and projects related to Technology & Data Solutions controls and compliance reporting
  • Establish processes to be audit ready at all levels of the organization and ensure an environment/culture of audit / regulatory awareness
  • Evaluate general and specific training needs; lead training delivery to support the control environment & associated control framework; communicate governance & compliance objectives, fostering a compliance & risk aware culture
  • Establish Validation center of excellence across Technology & Data Solutions

Knowledge and Skills
  • 10+ years of experience in a technical environment including o developing GXP procedural controls and educational materials, preferably in an academic or corporate technical setting in a clinical or pharmaceutical industry o overseeing both internal and external auditing processes o managing testing / validation services
  • 10+ years of personnel supervision # Experience and ability to create and effectively present concepts and materials to executive level staff
  • An SME level of understanding of the processes for technology governance, risk and compliance disciplines
  • Ability to work with all levels of internal and external clients. Willingness to collaborate with subject matter experts and team members to complete compliance delivery requirements and other business deliverables
  • Knowledgeable in Good Clinical Practices and Global Regulatory regulations
  • Knowledge of ITIL v3 and basic Industry IS best practices
  • Strong project management (including time management) and technical expertise, attention to detail, and excellent documentation and communication skills
  • Ability to work well in a team-based matrix environment with minimal supervision
  • Highly motivated, decisive, and results-oriented individual, with the flexibility and creativity to excel in a multi-project, high-pressure environment
  • Excellent analytical, problem- solving, decision-making abilities, and critical thinking skills
  • Strong attention to deliverables with accuracy and efficiency
  • Proven collaboration expertise
  • Strong customer service experience

Education and Experience
BA or BS in Computer Science, Technical Communications, Instructional Technology, or a related field, or an equivalent combination of relevant education and at least 10 years of experience in a GXP regulated industry required
Master's Degree preferred
Academic or Commercial Clinical Research Organization experience preferred

Requisition Number
401263448

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
2429 ASSOC DIR, IT

Job Family Level
E

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status. Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job 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.

Education

Refer to Job Description

Auto req ID

90017BR

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

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job 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.

PI98175942