Note: The job is a remote job and is open to candidates in USA. ImmunityBio, Inc. is a commercial-stage biotechnology company focused on developing cell and immunotherapy products to enhance the natural immune system. The Clinical Document Management Specialist role involves supporting clinical trials by managing essential study documents and ensuring compliance with regulatory guidelines.
Responsibilities
- Provides operational and administrative guidance for the study TMF/eTMF by assisting with the setup, organization, maintenance, and close-out of study specific TMF/eTMF
- Maintains and updates of Company’s standard TMF Plan and TMF index, including indexing, tracking, and filing of paper and electronic clinical trial documents
- Maintains the study TMF filing records system
- Collaborates with the Clinical Study teams to guide proper submission and/or filing of clinical study related documents for completion of required tasks to meet departmental and project goals
- Performs and oversees a review of documents filed in the TMF/eTMF as outlined by SOPs, company processes, procedures, and work instructions
- Oversight in preparing, handling, distributing, filing and archiving of clinical documentation and reports per standard procedures
- Collaborates in the review and improvement of SOPs and Departmental Policies and Procedures as it relates to TMF maintenance and archiving
- Performs the regularly scheduled QC of the overall TMF/eTMF per the TMF Plan by monitoring completeness and quality of the TMF
- Maintains internal audits and Regulatory Agency inspections by retrieving documents and providing reports
- 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 1+ years of clinical operations experience in pharma, biotech or CRO required; or
- High School diploma with 4+ years of clinical operations experience in pharma, biotech or CRO required
- Demonstrated knowledge of ICH and GCP guidelines
- Proficiency in MS Word, Excel, PowerPoint, Outlook
- Must be independent, flexible, and work well in a team environment, but also be self-directed and adapt to changing priorities and complete tasks under tight deadlines
- Understand job-specific systems and processes as defined by Company SOPs and adhere to requirements listed in those documents. If any procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager
- Solid communication skills and strong customer focus with the ability to interact in a cross functional organization
- Maintain corporate confidentiality at all times Dependability and timeliness
- Requires Critical Thinking skills, ability to lead co-workers, strong attention to detail, document organization skills, establishing priorities, scheduling, and meeting deadlines
- Trial Master File experience preferred
- Demonstrated knowledge of clinical trial documents is preferred
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
- We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
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