Clinical Trial Manager – CTM

🔥 2 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $140k - $155k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Kumquat Biosciences Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

💰 $70M Corporate Round on 2021-07

Healthcare • Biotechnology • Healthcare Insurance

Kumquat Biosciences Inc. is a biotechnology company dedicated to innovating life-changing medicines for cancer patients. With a focus on the KRAS pathway, Kumquat develops both single and combination therapies that target previously undruggable cancer types and stimulate the immune system to enhance therapeutic outcomes. Through a culture of bold innovation and collaboration, they strive to set new standards in cancer treatment, bringing the latest advancements from research to patient care.

📋 Description

• Perform day-to-day management of early phase clinical trials or support study leads 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 timely initiation, monitoring, and close-out of clinical trial sites, including selection of qualified investigative sites • Oversee patient recruitment and retention strategies • Oversee vendors and investigative sites in collecting and managing clinical data to fulfill study objectives • Proactively identify and mitigate risks and challenges throughout the trial • Ensure compliance with GCP guidelines, relevant regulations, and company protocols • Prepare for and manage regulatory audits and inspections

🎯 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 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 is a plus