Clinical Trial Manager (CTM)

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.

• 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