ASSOCIATE CHIEF OPERATING OFFICER, DCRI

Reporting to the Chief Operating Officer (COO)and a member of the Operations Management Team (OMT), this position will work closely with the COO on strategy development, operations management and process improvements, as well as quality and compliance. Additionally, they will be responsible for overseeing the operational performance of a sub-set of operations groups, with the Directors of those groups reporting directly to this position.

** 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., Washington (State), Connecticut

Primary Responsibilities and Task

Operations Strategy & Management

• Assist the COO in the development and implementation of operational strategies and goals.
• Assist the COO with oversight and management of the operational and strategic progress of the operations groups.
• Conduct comprehensive project reviews and risk management for DCRI’s collective portfolio of clinical research programs and projects, actively reviewing the top projects based on revenue to identify and mitigate any projects at risk.
• In collaboration with the COO, work with the CFO and Research Proposal Development leadership to assess fiscal requirements, develop study budgets, manage expenditures, and ensure payments are managed by the respective teams.
• Implement effective metrics and strategies to measure and improve operational efficiency, quality and service delivery of the operations teams.
• Communicate and cascade the operational metrics and expectations to the operations leaders and provide feedback and coaching.
• Analyze and report on operational data and trends and identify areas of improvement and opportunity.
• Develop and implement plans and strategies to ensure the quality and integrity of DCRI’s clinical data and compliance with the study protocols, SOPs, GCP, and applicable regulations.
• Identify opportunities to leverage and/or redesign processes, tools and technology to improve and/or increase efficiency of DCRI operations.
• Ensure resources are managed in an effective way across the sub-set of operations groups they oversee to achieve financial and business objectives.

Operational Excellence & Innovation

• Foster a culture of operational excellence, accountability, and collaboration across the organization.

• Sponsor, lead and/or participate in key DCRI-wide initiatives that support the strategic growth and development of the DCRI, as well as seek to enhance operational and translational capabilities, services and outcomes.

• Oversee the launch and implementation of these initiatives, ensuring that they are aligned with the DCRI’s vision, mission, and values.

• Collaborate with other senior leaders and stakeholders to evaluate the impact and effectiveness of these initiatives, and identify opportunities for improvement and innovation.

Quality & Compliance

• Responsible for being the overall operational point person for QA, QA escalations,   QSD compliance and audit/inspection readiness.

• Ensure the highest standards of quality and compliance for DCRI’s clinical research programs and projects, and address any issues or risks that may arise.

• Develop and implement escalation plans and strategies to resolve any quality issues or incidents, and ensure proper documentation and follow-up.

• Collaborate with other senior leaders and stakeholders to implement and maintain the QSD policies and procedures, and prepare the organization for internal and external audits and inspections.

• Ensure compliance with IRB regulations and policies, such as IRB expirations, informed consent forms, data sharing agreements, etc.

• Coordinate with Duke IRB and ORAQ staff on IRB-related matters, such as delay in IRB reviews/approval of DCRI studies, coordination of DCRI IRB submissions via IRIS, and oversight of the DOCR RPM for DCRI IRB  support.

Partnerships

• In collaboration with Vendor Management, cultivate key vendor/partner relationships.
• Work with various vendors, partners and Academic Research Organizations (AROs) to ensure the quality, efficiency, and compliance of the clinical research programs and projects.
• Collaborate with other senior leaders and stakeholders to leverage the best practices and resources from these vendors and partners and optimize the value and outcomes of these relationships.

Financial Management

• In collaboration with the COO, contribute to DCRI’s overall budget development to align operations goals with the budget.
• Oversee budgetary forecasts for their groups’ expenses (operating and capital) on an annual basis.
• Ensure appropriate utilization of resources and adherence to targets, monitoring expenditure of funds relative to budget and ensuring that appropriate interventions are implemented.

Personnel Management

• Demonstrate commitment to valuing diversity and contributing to an inclusive working environment and culture.
• Direct various personnel functions, including but not limited to, hiring, performance management, merit recommendations, promotions and work schedules.
• Provide career planning advice to staff and create 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.

Required Qualifications

Education/Training:

• Bachelor's degree required. Bachelor's degree in a health-related discipline (i.e., nursing, pharmacy or allied health profession) preferred.

Experience:

• Minimum of 12 years of progressively responsible experience in clinical research operations in a coordinating center environment (including 6 years in a leadership capacity) in the contract research, pharmaceutical, medical device, or biotechnology industry or in an academic research organization.

• Leadership experience in both academic and/or corporate environments. P&L management experience preferred.

Knowledge, Skills and Abilities:

• Proven track record of implementing and using effective operational tools and methodologies to ensure the quality and efficiency of clinical research operations
• Demonstrated knowledge and experience in the clinical research enterprise, including study design, execution, monitoring, data management, quality assurance, and regulatory compliance
• Proven ability to manage and oversee staff, providing feedback, coaching, and performance evaluation
• Excellent organizational skills, with attention to detail, accuracy, and documentation
•Comprehensive understanding of all aspects of DCRI capabilities, and how they support the clinical research activities and objectives
• Self-motivated and independent worker, able to work with minimal supervision and direction
• Effective prioritization and time management skills, able to handle multiple tasks and deadlines simultaneously
• Experience in partnering with external organizations, such as AROs, CROs, etc., to ensure the quality, efficiency, and compliance of clinical research programs and projects
• Community builder, with strong interpersonal and communication skills, able to bring people together and foster collaboration and trust
• Clinical experience is a plus, as it provides insight and perspective into the clinical research environment and challenges
• Knowledge of ICH GCP and regulatory requirements, and how theyapply to clinical research operations and processes
• Comfortable with different/new technologies, able to learn and adapt to new systems, tools, and methods
• Strong analytical, problem-solving, and decision-making skills
• Excellent communication, presentation, and interpersonal skills

Minimum Qualifications