Note: The job is a remote job and is open to candidates in USA. ImmunityBio is a commercial-stage biotechnology company developing therapies and vaccines for cancer and infectious diseases by harnessing the immune system. The Senior Clinical Trials Manager manages global clinical studies, supports study documentation and site operations, monitors patient data, and provides clinical protocol and safety guidance to study sites.
Responsibilities
- Assist Clinical Project Manager in the development and management of company-sponsored global clinical trials
- Lead in reviewing completed assignments by members of the clinical development group
- Lead/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 in-house team to ensure 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
- Lead/Assist in the training of clinical development group staff
- Assist CPM to prepare and update clinical trial updates for Clinical Development team
- Provide support for summarizing and maintaining patient treatment, response and survival data for active studies
- Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates
- Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities
Skills
- Bachelor's degree with 7+ years of relevant experience in clinical research required
- 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. 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
- This position works either on site in El Segundo, CA or remotely as noted in their offer letter
- This position will 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
Benefits
- Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
- Work with a collaborative team with the ability to work across different areas of the company.
- Ability to join a growing company with professional development opportunities.
- This position works either on site in El Segundo, CA or remotely as noted in their offer letter.
- This position is eligible for a discretionary bonus and equity award.
- Medical, Dental and Vision Plan Options
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- Healthcare and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
- Paid Time Off (PTO) includes: 11 Holidays
- Exempt Employees are eligible for Unlimited PTO
- Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
- We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
Company Overview
Company H1B Sponsorship