Clinical Monitoring Standards Lead

RDI

$90K — $130K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years of experience in clinical operations, specifically with IVD CRAs.
  • Deep understanding of clinical trial regulations and monitoring standards.
  • Experience implementing risk-based monitoring and AI-assisted workflows.
  • Strong teaching and mentorship skills for junior team members.
  • Proven track record of maintaining audit-readiness across multiple studies.

Responsibilities

  • Lead a team of junior CRAs and data-entry staff to uphold monitoring quality.
  • Develop and execute systems ensuring studies are inspection-ready.
  • Implement modern clinical trial monitoring techniques.
  • Conduct hands-on review of consent forms, source data, and CRF data.
  • Collaborate with leadership to report on study quality and status.
  • Engage directly in daily operational tasks alongside the team.
  • Ensure the continuous application of high standards across all conducted studies.

Benefits

  • Opportunity to shape and lead a high-performing clinical operations team.
  • Chance to modernize clinical trial methodologies within a growing company.
  • Collaborative and supportive work culture focused on professional growth.
  • Hands-on role allowing for direct impact and accountability in processes.
Full Job Description
The Role

Can you build a world-class team of IVD CRAs?

We have a passionate, caring, hard-working clinical operations team that wants to perfect its craft. We are looking for someone who can raise the standard across the team and make sure that standard holds across every study.

You will own monitoring quality and audit-readiness across RDI's diagnostic studies. You will develop the systems that demonstrate study quality and status to leadership and, where appropriate, to clients.

You will also help modernize clinical trial monitoring as the industry moves toward risk-based monitoring, real-time oversight, remote-first execution, and AI-assisted workflows without compromising quality.

You need real knowledge of the regulations and monitoring standards. If your understanding comes mainly from checklists, templates, or PowerPoints someone else made for you, this is not the right role.

This role is for a master of the craft: someone who can do the work, teach the work, inspect the work, and hold a team to the standard.
The Work

You will own audit-readiness across RDI's diagnostic studies and help lead a team of junior CRAs and data-entry team members.

The ideal candidate already knows what that means and has likely built or operated a system that keeps multiple studies inspection-ready at once.

This is not traditional management. RDI is a small, merit-based company, and no leader here gets to stay above the work.

You will dig into the details: reviewing an individual informed consent, checking source against CRF data, walking through query status, reviewing a binder, or finalizing a monitoring report alongside the team.

You are accountable for the standard holding in real work, not just existing in a document.
Location and Schedule

This role is strongest if based near our Los Angeles / Van Nuys office.

Remote candidates will be considered only if they have a proven method for learning our business, applying our standards, and managing quality across a remote team.

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