Clinical Document Management Specialist

ImmunityBio • El Segundo, CA

8d • $33 - $42 • Remote

About The Position

The Clinical Document Management Specialist supports clinical trials by processing both paper and electronic essential study documents against pre-specified quality criteria to include filing, routing, and coordination of documents to ensure compliance with applicable Standard Operating Procedures (SOPs) and regulatory guidelines.

Requirements

• 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

Nice To Haves

• Trial Master File experience preferred
• Demonstrated knowledge of clinical trial documents is preferred

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.

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
• This position is eligible for a discretionary bonus and equity award.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 501-1,000 employees