VIDA Diagnostics is a leading medical imaging CRO providing central imaging services for global clinical trials across oncology, pulmonology, cardiology, neurology, and other therapeutic areas. Our imaging experts partner with sponsors and CROs to define, execute, and deliver imaging endpoints that accelerate drug and device development.
The Project Manager, Clinical Trials, serves as the primary client-facing leader for a portfolio of 4–8 concurrent imaging studies. This role owns end-to-end project delivery—from imaging charter development and site qualification through data delivery and study close-out—while coordinating cross-functional teams internally and managing all sponsor and CRO relationships.
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
- Monitor 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.
- Working knowledge of HIPAA, Good Clinical Practice (GCP).
- 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.
All VIDA employees expected to be flexible and have an entrepreneurial mindset. Other duties may be assigned as needed.
VIDA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veteran’s status, age or disability.
