RESEARCH PROGRAM LEADER
$76.81k - $130.58kDuke Careers
School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations. Be Bold. Research Program Leader – Core Lab Operations (MB-108 Study) Summary: The Research Project Manager will oversee day-to-day project operations for the MB-108 Core Lab Study, a 5-year, multi-site research initiative involving centralized echocardiographic image analysis. This role is responsible for ensuring smooth coordination across participating sites, data integrity, compliance with protocol standards, and timely delivery of study outputs to the sponsor. The Project Manager will supervise the functional work of staff assigned to this project but will not serve as their direct manager of record. Key Responsibilities and Functional Breakdown 50% – Core Lab Oversight and Protocol Compliance
- Serve as the primary operational lead for the MB-108 Core Lab Study, coordinating activities between the Duke Clinical Data Unit (CDU) and sub-sites.
- Oversee receipt, tracking, and quality control of up to 3,700 echocardiographic image datasets submitted by participating sites.
- Ensure all image data are collected in accordance with protocol specifications and contractual obligations with the sponsor.
- Identify and resolve issues related to protocol deviations, site errors, or data inconsistencies; escalate problems when necessary to the Principal Investigator.
- Conduct detailed review of study files, ensuring image sets and associated documentation meet completeness and quality standards prior to analysis.
- Compile and maintain accurate project records, site logs, image receipt reports, and quality assessments.
- Track and report on protocol progress, image processing timelines, and delivery milestones using internal tracking systems and sponsor-facing dashboards.
- Prepare summary reports of Core Lab operations and outcomes for internal use and sponsor submission.
- Ensure all documentation complies with regulatory requirements and institutional data security standards.
- Plan and conduct virtual or in-person meetings with participating sites for training, updates, and troubleshooting.
- Coordinate and maintain site feedback mechanisms (e.g., post-training evaluations, compliance check-ins).
- Draft and update the MB-108 Core Lab Imaging Manual, providing technical and procedural guidance to participating sites.
- Lead rollout of updates to protocol documentation based on interim findings, sponsor input, or evolving best practices.
- Oversee day-to-day work assignments of CDU imaging analysts and technical staff supporting this project.
- Ensure clear distribution of tasks related to image receipt, processing, analysis, and reporting.
- Monitor workload distribution and recommend task adjustments to maintain project efficiency and quality.
- Serve as the point of coordination between analysts, CDU operations leads, and the study PI to align resource use with study goals.
- Identify problems in site-submitted image data or processing workflows and initiate appropriate corrective actions.
- Collaborate with the PI and technical staff to refine data handling and storage procedures using the single-vendor platform.
- Develop and implement Core Lab policies for data processing, standardization of measurements, and blinded review procedures.
- Evaluate opportunities to introduce process improvements or new technologies in image review, quality scoring, or delivery systems.
- Project: MB-108 Core Lab Study – centralized analysis of echocardiograms across multiple research sites.
- Scope: Up to 3,700 de-identified echocardiograms will be collected, analyzed, and archived.
- Technology: Proprietary single-vendor imaging platform with software-specific analysis tools for cardiac function assessment.
- Team Interaction: While this role coordinates and oversees project-assigned staff, direct supervisory authority does not apply. Instead, the position serves as the operational lead for all study-related activity.
- This role aligns with a Research Project Manager classification due to its high-level coordination of complex, multi-site research activities; operational leadership over project staff; oversight of protocol compliance; and responsibility for cross-site communication, documentation, and process implementation.
- Although it does not include formal direct reports, the majority of the responsibilities involve managerial-level duties essential to the success of a high-risk, sponsor-driven research project.
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