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.

20% - Documentation and Reporting
• 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.

10% - Site Training and Communication Coordination
• 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.

10% - Workflow and Staff Coordination
• 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.

10% - Quality Assurance and Process Development
• 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 and Technical Context
• 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.

Position Classification Context
• 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.

Knowledge, Skills and Abilities

Can easily use computing software and web based applications (e.g., Microsoft Office products andthe electronic medical record).

Level Characteristics

Can easily use computing software and web based applications (e.g., Microsoft Office products and the electronic medical record).

Minimum Qualifications

Education

Completion of a Bachelor's degree

Experience

Work requires a minimum of four years of research experience (e.g., research, clinical, interaction with study population, program coordination). A Master's degree may substitute for two years of related experience.

Degrees, Licensures, Certifications

Work requires a minimum of four years of research experience (e.g., research, clinical, interaction with study population, program coordination). A Master's degree may substitute for two years of related experience.

Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $76,811.00 to USD $130,576.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goesbeyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/