This Position is 100% Grant Funded

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.

Office of Regulatory Affairs and Quality, Project Leader, Systems

Job Title: Project Leader, Systems

OCCUPATIONAL SUMMARY

Leader/developer and architect for the EDMS (electronic document management system), Master Control, used by multiple Duke programs. Master Control is a system that securely stores and controls access to controlled documents. The system is validated, FDA compliant, and meets regulatory standards for electronic document control (21 CFR Part 11). MasterControl controls, automates, and streamlines the document flow processes. The leader is responsible for the design, configuration, deployment, and maintenance of the system. Direct, plan and develop processes and procedures for participating Duke programs to meet governmental and institutional compliance; and to serve the Master Control user community.

RESPONSIBILITIES

Independently or with very little oversight:

• MasterControl System Oversight
• Serve as lead developer for MasterControl design issues to provide for efficient environment.
• Create and implement policies describing the system operations of MasterControl.
• Create and implement policies for the MasterControl end users of all programs providing details for using and navigating the system.
• Create and provide quality “Q-Tips” of MasterControl system “how to guides” to users for reference tools.
• Coordinate and control of the workflow (processing, routing, storage, retrieval, printing, and distribution) of electronic documents in a secure and efficient manner, and ensure controlled records are accessible to authorized personnel when required.
• Serve as system representative in technical meetings regarding MasterControl.
• Import and maintain Active Directory (AD) MasterControl user credentials for identity management to ensure compliance with regulatory and Duke IT policies.
• Obtain MasterControl licensing quotes and other pricing information for potential new Duke programs.
• Review and approve invoices for MasterControl services rendered and/or licensing fees to ensure continuous coverage of the MSA (maintenance service agreement).
• Consult with management staff concerning MasterControl capabilities and technology. Provide feasibility guidance and cost estimates of system enhancements.

• Training
• Develop, coordinate, and instruct all MasterControl system training (online, classroom, or individual) across multiple programs.
• Prepare, manage, and deliver MasterControl presentations or WebEx’s to user groups or new Duke programs.
• Participate in the MasterControl Certification Program to maintain the “Master” certification level.
• Attend MasterControl educational training sessions as appropriate.
• Maintain an awareness of document generation and electronic document management to keep Duke programs in the forefront of evolving industry standards.

• System Maintenance/Troubleshooting
• Provide systematic troubleshooting of failed processes or system software and/or technical issues reported by users; be able to quickly diagnose a problem and determine how best it can be fixed in the shortest amount of time with minimal disruption to users.
• Determine the following factors and the services required when the MasterControl system requires a software upgrade:

w Scope w Business requirements

w Objectives w Risks and constraints

w Deliverables w Success criteria

w Stakeholders w Design parameters.

• Collaborate with IT to ensure upgrade programs/applications will match current hardware/software devices.
• Coordinate beta testing and system upgrades with onsite IT and MasterControl.
• Evaluate system requirements (MasterControl or computer needs) to determine potential enhancements or improvements to applications.
• Make provisions for planned IT maintenance outages; notify user community of system downtime; and provide coverage to IT maintenance team for MasterControl system verification to allow for a system restart.
• Detailed conceptual knowledge/understanding of MasterControl system operations and the planning for and responding to service outages and IT maintenance work.

• Inspections/Audits
• Participate, as lead Document Control contact, in internal audits under QSUs authority by providing regulatory agencies with MasterControl documentation for inspection and relevant information.
• Prepare, with extreme accuracy, the MasterControl narrative for the FDA BLA Annual Report.

• Personnel Management
• Arrange, provide, and maintain sponsorship status of non-Duke guests for MasterControl remote users through Duke OIT services.
• Develop and recommend MasterControl systems policies and procedures. Collaborate with Medical Director and Quality leadership on special team assignments or projects by organizing and coordinating information via MasterControl.
• Develop, implement and oversee various programs including, but not limited to, procuring necessary resources, screening ideas, and managing objectives and priorities to optimize effectiveness.
• Serve as liaison to Duke programs for MasterControl services. Participate in technical meetings and make recommendations of system usage and requirements.
• Serve as the main interface with project staff and MasterControl resources, i.e., MasterControl’s technical support team, analysts, sales support; and Duke IT services.
• Manage Document Control Operations personnel including, but not limited to, performance evaluations, hiring, salary rate recommendations, promotions, transfers, and vacation requests.

• Forms Creation and Design
• Implement online fillable PDF forms for use in MasterControl by providing interactive form-based processes for electronic routing and forms creation, such as deviations and CAPAs; ensure data in the forms can be identified and tracked for custom reporting output.
• Provide template creation and instructions for new Duke programs.

• Change Control
• Utilize the change control system to support quality, consistency, and to protect the integrity of controlled documents.
• Host monthly CCBB Change Control Committee meetings; prepare reports, agendas, and meeting minutes and distribute in a timely manner.
• Prepare and distribute Change Control Reports for other Duke programs.

EDUCATION

Required: Bachelor’s degree

EXPERIENCE

Required: Four years professional experience with full-cycle enterprise software development and support including data architecture design (transactional and warehousing), integration, and security. This should include 2 years experience with Web Services, Win and Web form development, as well as experience with complex application security models.

Preferred: A minimum of 5+ years professional experience with MasterControl, with a detailed conceptual knowledge of MasterControl system operations, including a comprehensive understanding of how the system works: system design, networking, system functionality, and technical requirements; execution of installation, operational, and performance qualification testing; template creation; and technical reporting. Thorough knowledge of 21 CFR Part 11 to ensure regulatory compliance.

OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

SKILLS

Required:

SQL/TSQL (triggers) C# XML/XLST.NET Webservices VB.NET ASP.NET PARIS

Preferred:

wA technical mind

wProject management

wInitiative

wProblem solving

wAttention to details

wWorking knowledge of JavaScript and HTML

wInterpersonal skills

wAbility to multi-task

wTime management

wGood written and verbal communication skills

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.