Clinical Trials Manager

Role Summary

The Clinical Trials Manager is responsible for managing the activities of several clinical studies including assisting in the development of study-related documents, study site management, and patient data monitoring. The role will provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.

Responsibilities

• Assist in the development and management of company-sponsored clinical trials
• Assist in reviewing completed assignments by members of the clinical development group
• Assist in the development and management of revisions to study-related documents such as the informed consent, laboratory manual, pharmacy manual, case report forms (CRFs) and other study execution tools
• Provide support in site recruitment, site initiation, site payments and site close-out
• Help to oversee the training of new clinical site staff or site training for protocol amendments
• Liaise with the regulatory department for the collection of updated regulatory documents as needed
• Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance
• Assist in the training of clinical development group staff
• Prepare and update clinical trial updates for Clinical Development team
• Lead/moderate DSMB teleconferences, monthly PI and Study Coordinator teleconferences
• Provide support for summarizing and maintaining patient treatment, response and survival data for active studies
• Performs other duties as assigned

Qualifications

• Bachelor’s degree in biological science with 5+ years of relevant experience in clinical research required

Skills

• Proficiency in MS Word, Excel, PowerPoint, Outlook
• Excellent written/oral communication skills as well as strong organizational and multi-tasking skills
• Understand the job-specific system and processes as defined by the company’s SOPs and adhere to the requirements listed in those documents
• Maintain corporate confidentiality at all times

Education

• Bachelor’s degree in biological science with 5+ years of relevant experience in clinical research required

Additional Requirements

• This position works on site in El Segundo, CA or remotely depending on the geographic location of the candidate
• Regular work schedule Monday – Friday, within standard business hours; flexibility with manager approval
• Exposure to an in-lab environment
• Approximately 20% travel
• Lift and carry materials weighing up to 20 pounds