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Senior Clinical Trial Manager

hace 1 mes

Ponce, Ponce, Puerto Rico Immunitybio A tiempo completo
Job Title: Senior Clinical Trial Manager

At ImmunityBio, we are seeking a highly skilled Senior Clinical Trial Manager to join our team. As a key member of our clinical development group, you will be 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.

Key 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
Requirements:
  • BA/BS degree with 7-10 working experience in clinical research
  • 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
Working Environment:

This position works hybrid (combination on-site and remote). This position will be exposed to an in-lab environment. 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:

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include:

  • 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
Equal Opportunity Employer:

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Mandatory Vaccination:

ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.