Chief Research & Technology Officer, DCRI

Position Summary

Dedicated to enhancing global health through innovative clinical research, the Duke Clinical Research Institute (DCRI) stands as an independent academic research institution associated with the Duke University School of Medicine (SOM). At the core of its mission is the conduct and coordination of clinical trials, research networks, and implementation science projects, both nationally and internationally. Emphasizing patient-centered clinical research, DCRI faculty collaborates with experienced operations teams to design and implement studies that improve health outcomes. To meet its mission, the DCRI continuously advances new research methods that it develops and applies turning data into knowledge across the entire spectrum of clinical research. Rooted in its commitment to developing and sharing knowledge, the DCRI strives to make a lasting impact on local to global health.

Position Summary: Taking a pivotal role in this mission, the Chief Research Technology Officer (CRTO) will have primary responsibility for envisioning, designing, delivering and managing the lifecycle of the research technology stack and portfolio for the Duke Clinical Research Institute (DCRI). This leader will build trusted relationships and active dialogue with DCRI operations, therapeutic areas, and all essential operational units within DCRI and with the broader technology leadership across Duke University.

The successful candidate will be an experienced IT professional with strong leadership and a demonstrated track record in establishing high-performing cultures and delivering complex IT solutions in a matrix organization. The CRTO will be a collaborative partner who can build trust and credibility with constituents across the DCRI, Duke University and work with partners to develop an inclusive and successful strategy to support the rapidly evolving research technology and IT needs for the DCRI. The CRTO will be a forward-thinking, innovative leader with knowledge of new trends in technology supporting research and the ability to lead change effectively in a growing and evolving matrixed organization and university.

** NOTE: This position may have an opportunity to work remotely. All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC.

Primary Responsibilities and Task

Strategy & Innovation:

• Overall responsibility for developing and deploying strategic and operational plans and execution that transform technology delivery at DCRI. This includes technology innovation for advancing clinical research (e.g., positioning DCRI for early adoption of AI).
• Using a modern SDLC, clarifies and reinforces rigor and process in a lightweight and agile approach.
• Responsible for organizing work into a Plan-Build-Run execution model that establishes clear accountability and expectations for internal and external customers, stakeholders and sponsors.
• Provides strategic organizational leadership to enable coordination between central and distributed IT units including the identification of synergies with Duke University and Duke University Health System (DTHS).
• Establishes a robust and secure technology landscape that is considered a leader in technological capabilities to fully meet the needs of a large and rapidly growing research portfolio in the coming years.
• Provides strategic and operational leadership in advancing innovation and digital transformation initiatives across the University to further Duke's impact on advances in biomedical research.
• Acts as a trusted advisor and partner within and outside of DCRI, including with the SOM and DHTS IT Leadership.
• Oversees the management of strategic technology partner and vendor relationships.
• Represents the organization externally on technology matters and comfortabley interfaces directly with key commercial customers and federal agencies on project related concerns and potential business development.
• Demonstrates commitment to valuing diversity and contributing to an inclusive working environment and culture.

Operations Leadership:

• Accountable for the successful delivery of a diverse technology and services portfolio that serves all of DCRI.
• Stays abreast with all applicable FDA, GCP, PHI and SEI regulations.
• Ensures compliance with all computer system validation, privacy and security related regulations including government and other standards such as FISMA and GDPR.
• Develops a sound and usable software development lifecycle management (SDDLC) methodology that clearly articulates the purpose, capabilities, deliverables and schedule for every effort undertaken.
• Overall accountable for disaster recovery, high availability and system data integrity.
• Develops a robust and collaborative resourcing model where DCRI employees take ownership of vision, architecture, capability, and communications, while fostering external partnerships for effective execution.
• Ensures appropriate resourcing and prioritization that aligns with the overall mission of DCRI Technology Solutions.
• Builds strong Esprit De Corps within own line management and across essential partnerships to enhance collaboration and team effectiveness.
• Responsible for building a performance-based culture that communicates early and often with all key stakeholders and partners.

Financial Management:

• In collaboration with the Chief Financial Officer (CFO) and all other internal stakeholders, has overall accountability for managing the entire technology budget as well as the development of long-range technology financial planning.
• Builds a prospective component-based architecture for DCRI that will be delivered using an investment mix of at least 50% sponsor and program-derived funding that will be deliverable based upon key program milestone dates.

Personnel Management:

• Builds the technology workforce of the future as well as maximizes the utility of the integration of the Crucible into DCRI.
• Recruits, mentors, and retains highly skilled technical resources and motivates them to act as a unified team on an ongoing basis, including contract and partnered staff.
• Directs various personnel functions, including but not limited to, hiring, performance management, merit recommendations, promotions and work schedules.
• Provides career planning advice to staff and creates development plans to help staff achieve their career goals including assigning work which leverages their skills and capabilities and provides them with opportunities for learning.

Other Duties

Performs other related duties incidental to the work described herein.

Education/Training:

• BA/BS degree in Computer Science, Information Technology, Informatics, Data Science or Business Administration
• Prefer advanced degree (MS/Phd.) in Computer Science, Information Technology, Informatics, Data Science or Management

Experience:

• 15 years of related progressive Information Technology leadership and delivery experience with 5 years Director level management experience in the contract research, pharmaceutical, medical device, or biotechnology industry or in an academic research organization.

Knowledge, Skills, and Abilities:

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  Effective communication, both written and verbal, including translating technical information for non-technical stakeholders.

  
  
• Fostering a collaborative and inclusive work environment.
• Understanding strategic visioning and design in the context of research technology, with the ability to establish and communicate a clear vision for integrating technology within the research landscape.
• In-depth understanding of complex IT solutions and experience managing matrixed organizations.
• Proficiency in leading IT teams, establishing high-performing cultures, and navigating matrixed organizational structures.
• Delivering complex IT solutions while adapting to the evolving needs of a growing and matrixed organization and university.
• Knowledge of SDLC
• High level of proficiency in making operations run smoothly and effectively, resulting in better overall performance.
• Knowledge of Analytics, Business Intelligence & Visualization
• Possess Program & Project Management expertise.
• Knowledge of Agile & DevOps
• Knowledge of Computer System Validation
• Knowledge of Data Standards, Architecture & Management
• Knowledge of Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and electronic Trial Master File (eTMF).
• Functional knowledge of structured randomized clinical trials
• Knowledge of Electronic Health Record (EHR) platforms, Fast Healthcare Interoperability Resources (FHIR), Health Level Seven (HL7), and various integration standards.
• Knowledge of Cloud platforms (e.g., AWS, Azure, GCP, SFDC, Medidata)
• Strategic business and industry awareness and the ability to translate emerging industry trends relevant to the organization.
• Prioritize and handle multiple tasks in a dynamic environment.
• Knowledge of CRO, pharmaceutical, biotech development, or health care industry required.
• Provide strategic level input and the ability to influence others at all levels of the organization.

Refer to Job Description

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.