[Remote] Senior Clinical Research / Trials Project Manager 100% Remote

Note: The job is a remote job and is open to candidates in USA. The hiring client is a medical center within a California public university and health delivery system. The Senior Project Manager supports and oversees investigator-initiated clinical research studies, coordinating study teams and supporting protocol development, regulatory submissions, documentation, and data quality.

Responsibilities

• The Senior Project Manager (Sr. PM) of the Clinical Trials Development (CTD) Team will participate in all Investigator Initiated Trial (IIT) research activities as part of the clinical research team
• The Sr. PM will provide project management support and oversight for assigned investigator-initiated clinical research studies
• Serve as the primary point of contact for investigators, regulatory coordinators, study coordinators, data managers, research staff, and study monitors
• Provide project management support and oversight for assigned investigator-initiated clinical research studies
• Ensure accurate and timely writing of protocols and study documents
• Assist with the preparation and completion of FDA IND, DSMB, IRB, and other regulatory submissions
• Review and follow up on study data and monitoring findings
• Assist with maintaining regulatory files to fulfill research requirements and meet established study timelines
• Collaborate with study teams and study monitors to support data quality
• Ensure study documentation is complete, accurate, and maintained in a timely manner
• Manage assignments from the team Director and study investigators, adjusting priorities based on study and departmental needs
• Ensure studies and patient care needs are addressed appropriately and in a timely manner

Skills

• Candidate must be authorized to work in USA without requiring sponsorship
• Experience or demonstrated ability in clinical research project management, preferably involving Investigator Initiated Trials (IITs)
• Knowledge of clinical research protocols, study documentation, and regulatory processes
• Familiarity with FDA IND, DSMB, IRB, and other regulatory submissions
• Ability to review study data, address monitoring findings, and maintain accurate regulatory documentation
• Strong organizational and time management skills, with the ability to meet established study timelines
• Ability to work independently and collaboratively with multidisciplinary research teams
• Strong written communication skills, particularly in protocol and study document preparation
• Excellent interpersonal and communication skills to coordinate with investigators, research staff, and study monitors
• Ability to manage multiple assignments and adjust priorities based on changing study and departmental needs
• Strong attention to detail and commitment to maintaining data quality and documentation accuracy

Benefits

• 100% remote role

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