Clinical Trials Manager

ImmunityBio, Inc.•Mariposa, NY

1d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in biological science with 5+ 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.

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.

Benefits

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