Research Program Leader

Overview

The Research Project Manager will oversee day‑to‑day operations for the MB‑108 Core Lab Study, a five‑year, multi‑site research initiative involving centralized echo cardiographic image analysis. The role ensures coordination across participating sites, data integrity, protocol compliance, and timely delivery of study outputs to the sponsor. The Project Manager supervises functional work of staff assigned to the project but does not serve as their direct manager of record.

• 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 echo cardiographic 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; elevate problems to the Principal Investigator when necessary.
  • 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 (including post‑training evaluations and 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: 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. 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…