Senior Project Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Provide management support and oversight for assigned investigator-initiated clinical research studies.

• Operate under the guidance of investigators and the leadership of the clinical research unit.

• Act as the main point of contact for investigators, regulatory bodies, study coordinators, data managers, research personnel, and study monitors.

• Accurately write protocols and study documents within established timelines.

• Assist in the preparation and completion of regulatory submissions including FDA IND, DSMB, and IRB.

• Review study data and monitoring findings, and follow up as necessary.

• Collaborate with study teams and monitors to enhance data quality.

• Maintain regulatory files, ensuring that all study documentation is comprehensive, precise, and up to date.

• Manage tasks assigned by the team director and study investigators.

• Adjust priorities according to the needs of the study and department.

• Ensure that study and patient care requirements are met promptly and appropriately.

⛳️ Requirements

• Experience or proven capability in managing clinical research projects.

• Familiarity with clinical research protocols, study documentation, and regulatory procedures.

• Knowledge of FDA IND, DSMB, and IRB submission processes.

• Experience with Investigator Initiated Trials (IITs) is preferred.

• Capability to work remotely from 8:00 AM to 5:00 PM.

• Availability to work 40 hours per week.

🏝️ Benefits

• W2 employment.

• Group medical insurance.

• Dental insurance.

• Vision insurance.

• Life insurance.

• Retirement Savings Program.