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Avispa

Senior Project Manager

Avispa

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

Posted 10/22/2026full-timeRemote • California • United StatesSenior💰 $60 per hourWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in clinical research project management, including protocol writing, regulatory submissions, and data quality oversight. Proficient in managing investigator-initiated trials and ensuring compliance with FDA and IRB requirements.

Highest-signal resume keywords
Clinical Research Project ManagementFDA IND SubmissionsIRB SubmissionsInvestigator Initiated Trials (IITs)Regulatory Processes

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Protocol WritingStudy DocumentationData Quality ManagementRegulatory File MaintenanceMonitoring Findings Review
Soft Skills
CollaborationCommunicationAdaptabilityTime Management
Industry Keywords
Clinical ResearchStudy CoordinatorsData ManagersStudy MonitorsClinical Research Unit Leadership

About the role

Key responsibilities & impact
  • Provide project management support and oversight for assigned investigator-initiated clinical research studies
  • Work under the direction of investigators and clinical research unit leadership
  • Serve as the primary point of contact for investigators, regulatory and study coordinators, data managers, research staff, and study monitors
  • Write protocols and study documents accurately and on time
  • Help prepare and complete FDA IND, DSMB, IRB, and other regulatory submissions
  • Review and follow up on study data and monitoring findings
  • Collaborate with study teams and study monitors to support data quality
  • Maintain regulatory files and ensure study documentation is complete, accurate, and current
  • Manage assignments from the team director and study investigators
  • Adjust priorities based on study and departmental needs
  • Ensure study and patient care needs are addressed appropriately and on time

Requirements

What you’ll need
  • Experience or demonstrated ability in clinical research project management
  • Knowledge of clinical research protocols, study documentation, and regulatory processes
  • Knowledge of FDA IND, DSMB, and IRB submissions
  • Experience with Investigator Initiated Trials (IITs) is preferred
  • Ability to work remotely from 8:00 AM to 5:00 PM
  • Ability to work 40 hours per week

Benefits

Comp & perks
  • W2 employment
  • Group medical insurance
  • Dental insurance
  • Vision insurance
  • Life insurance
  • Retirement Savings Program