Note: The job is a remote job and is open to candidates in USA. UCLA’s Department of Medicine, Division of Hematology Oncology, seeks a Senior Project Manager to support its Clinical Trials Development team. The role oversees investigator-initiated clinical trials, coordinates study documentation and regulatory submissions, and helps ensure data quality, compliance, and timely completion.
Responsibilities
- Manage and oversee assigned investigator-initiated clinical research studies
- Serve as the primary point of contact for Principal Investigators, regulatory coordinators, study coordinators, data managers, research staff, and study monitors
- Coordinate the preparation and review of clinical trial protocols and study documentation
- Support FDA IND, DSMB, IRB, and other regulatory submissions
- Review study data, follow up on monitoring findings, and support data quality
- Maintain accurate, complete, and up-to-date regulatory files and essential study documents
- Track study timelines, deliverables, and action items to ensure timely completion
- Collaborate with multidisciplinary research teams to address study priorities and operational challenges
- Ensure compliance with applicable FDA regulations, ICH-GCP guidelines, and institutional research requirements
Skills
- Experience in clinical research project management or clinical trial operations
- Experience with investigator-initiated trials (IITs), preferably in oncology or hematology-oncology
- Knowledge of clinical research protocols, regulatory documentation, and IRB processes
- Familiarity with FDA IND applications, DSMB reporting, and clinical trial regulatory requirements
- Experience coordinating with investigators, research teams, and study monitors
- Excellent organizational, communication, documentation, and time-management skills
- Ability to manage multiple studies and competing priorities independently
- Experience in an academic medical center or university research environment
- Experience with oncology clinical trials and investigator-sponsored research
- Familiarity with EDC, CTMS, and electronic trial master file systems
Benefits
- Fully remote work
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