Clinical Trial Manager

Research & Development Institute, Inc.; Los Angeles (CA); Remote; USD 80,000 - 120,000; Full time

Job summary

A leading company in diagnostics is seeking a Clinical Trial Manager to oversee in vitro diagnostic studies. The role involves managing trial operations, ensuring compliance with regulatory standards, and collaborating with sponsors and teams across time zones. Ideal candidates will have experience in clinical trials, strong project management skills, and a relevant degree. This position offers the opportunity to work in a fast-paced, startup-like environment while contributing to meaningful clinical research.

Qualifications

• 3–7 years experience in clinical trials, preferably IVD or diagnostics.
• Strong working knowledge of GCP, ISO 20916, and CLIA-waived studies.

Responsibilities

• Lead day-to-day operations for assigned diagnostic clinical trials.
• Ensure adherence to protocols, GCP, ISO 20916, and FDA/CLIA requirements.

Skills

Communication

Project Management

Regulatory Compliance

Education

Bachelor's degree in life sciences

Tools

Viedoc

Medrio

Job description

Job Title: Clinical Trial Manager

Location: Remote (US hours preferred)

Reports To: Chief Operating Officer (COO)

About Us

Research & Development Institute (RDI) is a diagnostics-focused Contract Research Organization (CRO) that partners with IVD companies to run high-quality, fast-paced clinical studies. We've supported 200+ trials and work with leading diagnostics and biotech companies to accelerate their path to market.

We operate like a startup-lean, fast, and hands-on-but with the infrastructure and expertise of a seasoned CRO.

Role Overview

We're looking for a Clinical Trial Manager (CTM) who can lead and execute in vitro diagnostic studies from startup to closeout. You'll own site management, monitor study progress, coordinate with sponsors, and ensure regulatory compliance. You must be comfortable working across time zones, juggling competing priorities, and operating independently.

Responsibilities

• Lead day-to-day operations for assigned diagnostic clinical trials
• Develop and manage study timelines, site initiation, and monitoring plans
• Oversee site selection, training, and performance
• Serve as primary point of contact for sponsor and cross-functional teams
• Ensure adherence to protocols, GCP, ISO 20916, and FDA/CLIA requirements
• Manage vendor relationships, including central labs and eCRF providers
• Drive data collection and query resolution alongside the Clinical Data Manager
• Support regulatory submissions and audit readiness
• Contribute to process improvement and SOP development

Qualifications

• 3–7 years experience in clinical trials, preferably IVD or diagnostics
• Prior experience at a CRO or in a startup environment strongly preferred
• Strong working knowledge of GCP, ISO 20916, and CLIA-waived studies
• Proven ability to manage timelines, vendors, and remote sites
• Clear written and verbal communication; comfortable leading calls with investigators and sponsors
• Ability to self-manage and thrive in an unstructured, fast-paced setting
• Bachelor's degree in life sciences or related field; advanced degree a plus

Nice to Have

• Experience with point-of-care or OTC diagnostic studies
• Familiarity with tools like Viedoc, Medrio, or custom eCRFs