Senior Project Manager – Clinical Trials Development (Remote)
Company: Pinnacle Technology
- Location: United States
- Work mode: Remote
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
📢 Now Hiring: Senior Project Manager – Clinical Trials Development
📍 Location: Fully Remote
📅 Duration: 3-Month Contract
🕗 Schedule: 8:00 AM – 5:00 PM
💲 Bill Rate: $55-60/hour
🏥 Client: UCLA – Department of Medicine, Division of Hematology Oncology
Position Overview
We are seeking an experienced Senior Project Manager to support UCLA’s Clinical Trials Development (CTD) team in overseeing investigator-initiated clinical trials (IITs). The ideal candidate will have a strong background in clinical research operations, regulatory compliance, study documentation, and cross-functional project coordination.
Key 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.
Required Qualifications
- 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.
Preferred Qualifications
- 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.
📩 Interested candidates: Please send your resume via LinkedIn message or contact your recruiter for additional details.
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