Clinical Trial Manager – CTM

This is a fully remote position, open to applicants in California.

📋 Description

• Manage the daily operations of early phase clinical trials, or assist study leads on multiple complex global clinical studies.

• Create and implement clinical trial plans, which encompass study timelines, budgets, and allocation of resources.

• Oversee trial budgets, contracts, and relationships with vendors.

• Work in partnership with investigators, clinical sites, and key opinion leaders to ensure effective execution of trials.

• Guarantee the prompt initiation, monitoring, and closure of clinical trial sites, including the selection of qualified investigative sites.

• Supervise strategies for patient recruitment and retention.

• Manage vendors and investigative sites in the collection and handling of clinical data to achieve study objectives.

• Proactively identify and address risks and challenges throughout the trial process.

• Ensure adherence to GCP guidelines, relevant regulations, and company protocols.

• Prepare for and manage regulatory audits and inspections.

⛳️ Requirements

• A Bachelor's degree in a relevant field (such as Life Sciences, Nursing, etc.), or equivalent professional experience.

• A minimum of 6 years of experience in clinical operations or related drug development, including at least 2 years with a sponsor company.

• Experience in managing vendors or clinical service providers is required.

• Comprehensive knowledge of GCP, ICH guidelines, and regulatory requirements pertaining to clinical research.

• Strong skills in clinical study execution, leadership, and project management are essential.

• Proven experience in data cleaning and management to support study objectives and data deliverables.

• Exceptional communication, collaboration, and problem-solving skills.

• Proficiency in Microsoft Office applications, clinical trial management systems, and electronic data capture systems.

• Willingness to travel to investigational sites as necessary.

• Familiarity with early phase clinical trial protocols and procedures is an advantage.

🏝️ Benefits

• Comprehensive health, dental, and vision insurance.

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and career advancement.

• Flexible work environment and supportive team culture.