Director, Clinical Operations
Arvinas
Google Cloud Platform
Clinical Trial Manager
Kumquat Biosciences Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $125,000 - $150,000 per year
Job Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- 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.
Benefits
- Fully remote work 📊 Resume Score Upload your resume to see if it passes auto-rejection tools used by recruiters Check Resume Score
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial managementclinical study executiondata cleaningresource allocationbudget managementrisk mitigationpatient recruitmentvendor managementcompliance with GCPregulatory requirements
Soft skills
leadershipproject managementcommunicationcollaborationproblem-solving
