Senior Clinical Trials Manager

Position Summary
Responsible for managing the activities of several global clinical studies, including assisting in the development of study-related documents, study site management, and patient data monitoring. Provide guidance to clinical sites daily, including protocol interpretation and protocol safety compliance.

Essential Functions
- Assist Clinical Project Manager (CPM) in the development and management of company-sponsored global clinical trials
- Lead in reviewing completed assignments by clinical development group members
- Lead/assist in developing and managing revisions to study documents (informed consent, laboratory manual, pharmacy manual, CRFs, and other study execution tools)
- Support site recruitment, site initiation, site payments, and site close-out
- Oversee training of new clinical site staff and training for protocol amendments
- Liaise with in-house teams to collect updated regulatory documents as needed
- Provide daily guidance to clinical sites on protocol interpretation and protocol safety compliance
- Lead/assist in training clinical development group staff
- Assist CPM to prepare and update clinical trial updates for the Clinical Development team
- Summarize and maintain patient treatment, response, and survival data for active studies

Education & Experience
- Bachelor’s degree with 7+ years of relevant clinical research experience (required)

Knowledge, Skills, & Abilities
- Proficiency in MS Word, Excel, PowerPoint, Outlook
- Excellent written/oral communication; strong organizational and multi-tasking skills
- Understand and follow job-specific SOPs; notify supervisor if unclear
- Maintain corporate confidentiality at all times

Working Environment / Physical Environment
- On-site in El Segundo, CA or remotely (based on location); exposed to in-lab environment
- Travel ~20%; mobility for office work; lift/carry up to 20 lbs