Clinical Trials Manager

Role Summary

The Clinical Trails 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‚Äôs degree in biological science with 5+ years of relevant experience in clinical research required

Knowledge, Skills, & Abilities

• 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‚Äôs SOPs and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager.
• Maintain corporate confidentiality at all times.

Working Environment / Physical Environment

• This position works on site in El Segundo, CA or remotely depending on the geographic location of the candidate.
• Regular work schedule is Monday ‚Äì Friday, within standard business hours. Flexibility is available with manager approval.
• This position will be exposed to an in-lab environment.
• This position may travel approximately 20% of the time.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Lift and carry materials weighing up to 20 pounds.