Project Manager Clinical Trials

Responsibilities

• Study Leadership & Sponsor Management
• Serve as the primary point of contact for sponsors and CROs for all project-specific matters throughout the study lifecycle.
• Lead imaging study start-up, including development of the imaging charter, imaging endpoint definitions, KPIs, communication plan, and risk management plan.
• Ensure study deliverables are provided to Sponsor/CRO on schedule with high quality.
• Manage study maintenance and close-out activities, ensuring all deliverables are completed on time and to quality standards.
• Assess and communicate the impact of scope changes; lead change order process and obtain sponsor approval.
• Imaging Operations
• Coordinate imaging site qualification process with Sponsor/CRO, ensuring review of site imaging equipment requirements against protocol requirements.
• Maintain imaging site training and ongoing compliance with imaging protocols, escalating site deviations and coordinating corrective actions with Sponsor/CRO.
• Monitor DICOM data receipt, analysis, reconciliation, and escalation workflows within VIDA and with third party analysis providers, providing escalation and issue resolution support when needed.
• Timeline, Risk & Project Tracking
• Develop and maintain detailed project schedules; track study progress against milestones and proactively identify risks or delays. Communicate with Sponsor/CRO study management to ensure project status is understood, and collaborate on issues resolution.
• Own project budget tracking, both internal and with third party providers, providing regular forecast information, identification of out-of-scope activities, and oversee the preparation of change orders.
• Report project status, metrics, and financial data to internal leadership and as input to finance for invoicing.
• Escalate project risks with recommended mitigation strategies to Clinical Trials management, and when appropriate, the Sponsor/CRO.
• Cross-Functional Coordination
• Partner cross-functionally with imaging scientists, data management, clinical engagement, and IT/customer support to meet study objectives.
• Facilitate internal kickoff meetings, team huddles, and sponsor calls; document action items and drive resolution.
• Contribute to process improvement initiatives and SOP development within the Project Management function.

Qualifications

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Health Sciences, or a related field.
• Minimum 3 years of clinical trial project management experience, preferably at a CRO or imaging CRO; sponsor-side experience also considered.
• Demonstrated ability to manage multiple concurrent studies and prioritize in a fast-paced, deadline-driven environment.
• Exceptional written and verbal communication skills, including experience presenting to sponsor stakeholders.
• Strong attention to detail and commitment to data quality.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project).

Preferred Qualifications

• Direct experience with central imaging services for clinical trials, including DICOM workflows, imaging charter authorship, or imaging site qualification.
• Familiarity with imaging modalities relevant to clinical trials (CT, MRI, PET, ultrasound) and associated acquisition parameters.
• Knowledge of 21 CFR 812 (medical device regulations) and/or ISO 13485
• Experience with clinical trial management systems (CTMS), electronic trial master files (eTMF), or imaging data platforms (e.g., Medidata, Veeva Vault, IXICO, or similar).
• Proficiency with project management or tracking platforms (e.g., Smartsheet, Asana, or equivalent).
• PMP certification or equivalent project management credential.