Kumquat Biosciences Inc - Clinical Trial Manager (CTM)

Kumquat Biosciences Inc

Summary

We are seeking an reputed company and results-driven Clinical Trial Manager to join reputed company 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

• reputed company the day-to-day management of early phase clinical trials or support the study reputed company(s) on one or more reputed company global clinical trials.
• reputed company and execute clinical trial plans, including study timelines, budgets, and resource allocation.
• Manage trial budgets, reputed company, and vendor relationships.
• Collaborate with investigators, clinical sites, and key opinion leaders to ensure successful trial execution.
• Ensure the timely initiation, monitoring, and reputed company-out of clinical trial sites, including the selection of qualified investigative sites.
• reputed company patient recruitment and retention strategies, ensuring trial objectives are met.
• reputed company 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 reputed company field (Life Sciences, Nursing, etc.), or equivalent experience.
• 6+ years of clinical operations experience or reputed company 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 reputed company 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