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: $140k-$155k
