CLINICAL TRIALS PROJECT LEADER I

Clinical Trials Project Leader I The Outcomes Project Leader I position provides leadership to the department and to projects for application of information technology and health services research data management. This includes identifying research and business objectives and informatics solutions utilized in clinical research and health services data management operations. The position oversees assigned projects and actively develops more efficient and effective data management support for research projects supported by the department. Responsibilities Lead and supervise project activities, assign work, review completeness and accuracy, and provide feedback to team members. Manage staff and support administrative processes for the group and overall department. Provide technical, fiscal, and management oversight for assigned projects of moderate complexity or parts of larger projects. Collaborate with faculty to develop project objectives, methodology, and operational solutions that meet scientific and strategic goals. Consult with collaborating organizations and vendors on data integration, related regulations, and implementation of project requirements. Participate in industry initiatives, professional society administration, and conference planning and delivery. Capture lessons learned as a routine part of the project lifecycle and create mechanisms for informatics and outcomes issues to be collected and communicated. Manage internal and external customer expectations and ensure compliance with regulations and policies. Lead functional group activities supporting research projects, including requirement gathering, product evaluation, system design and customization, data structure design, technical specifications, and associated documentation. Represent the user perspective when designing technical solutions and facilitate discussions with clinical and technical teams. Develop and maintain expertise in electronic health records, PCORnet Common Data Model, best practices for data integration and quality, statistical principles for data management, terminology and coding dictionaries, codelist development, relational and analytical database design, programming languages, and distributed data network transfer and query methods. Focus on efficient and easily adopted methods for integrating different types of data (clinical, administrative, payment, bio‑specimens, and novel data sources) across systems or organizations. Perform technical support tasks: problem space analysis, writing specifications, data modeling, programming, systems testing, and troubleshooting. Consult on or provide direct support for complex research efforts with significant health services research components across the Duke community and collaborators. Identify and support the development, adoption, and use of tools, templates, and best practices across projects. Provide training to internal and external partners on the value, role, and methodology of pragmatic health services research, including the use of EHR, payer, site, and patient‑reported data for clinical and policy research. Conduct training sessions for internal and external staff, present at conferences, and publish in peer‑reviewed journals. Contribute to department training and development infrastructure. Qualifications Education: Graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician’s Assistant (PA), or Pharmacist, plus two years of healthcare experience; or one of the following equivalents: Allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) plus a minimum of five years healthcare experience. Master’s degree in public health, health administration, or a related area with one year directly related clinical trials research experience. Bachelor’s degree plus a minimum of three years directly related experience in clinical trials research. Bachelor’s degree plus a minimum of four years closely related research experience. Experience: One year directly related clinical trials research experience is required; no additional experience is required beyond what is specified above. Skills: No specific technical skills are listed beyond the educational and experiential requirements. State of North Carolina license may be required. Equal Opportunity Employer Duke is an 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 (including pregnancy and pregnancy‑related conditions), sexual orientation, or military 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 reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: View email address on click.appcast.io; phone: View phone number on click.appcast.io). #J-18808-Ljbffr Duke University