Apply
Clinical Trial Manager (CTM)
Fully Remote • San Diego
Apply
Description

Summary:


We are seeking an experienced and results-driven Clinical Trial Manager to join our team at Kumquat Biosciences. As a Clinical Trial Manager, you will play a pivotal role in planning, executing, and overseeing oncology clinical trials. You will be responsible for managing cross-functional teams, ensuring study milestones are met, and that trials are conducted in compliance with regulatory guidelines and company protocols.


Key Responsibilities:


  • Perform the day-to-day management of early phase clinical trials or support the study lead(s) on one or more complex global clinical trials.
  • Develop and execute clinical trial plans, including study timelines, budgets, and resource allocation.
  • Manage trial budgets, contracts, and vendor relationships.
  • Collaborate with investigators, clinical sites, and key opinion leaders to ensure successful trial execution.
  • Ensure the timely initiation, monitoring, and close-out of clinical trial sites, including the selection of qualified investigative sites.
  • Oversee patient recruitment and retention strategies, ensuring trial objectives are met.
  • Oversee vendors and investigative sites in the collection and management of clinical data to fulfill study objectives.
  • Proactively identify and mitigate risks and challenges throughout the course of the trial.
  • Ensure strict compliance with Good Clinical Practice (GCP) guidelines and relevant regulations.
  • Prepare for and manage audits and inspections by regulatory authorities.
Requirements
  • Bachelor's degree in a related field (Life Sciences, Nursing, etc.), or equivalent experience.
  • 6+ years of clinical operations experience or related drug development with 2+ years at a sponsor company.
  • Vendor/clinical service provider management experience required.
  • In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical research.
  • Strong clinical study execution, leadership, and project management skills required.
  • Demonstrated experience in data cleaning and management to support study objectives and data deliverables.
  • Excellent communication, collaboration, and problem-solving abilities.
  • Proficiency in using Microsoft Office applications, clinical trial management systems, and electronic data capture systems.
  • Willingness to travel to investigational sites as required.
  • Familiarity with early phase clinical trial protocols and procedures a plus.

Salary Description: $125k-$150k

Apply
View All Jobs