Trial Master File Analyst

Position Summary

The Trial Master File (TMF) Analyst will maintain the TMF through the planning and execution of trial activation and trial closeout as well as contribute to and provide oversight of TMF maintenance activities.

The role will partner with Clinical Records Management (CRM) on TMF deliverables including, maintenance, and review. The TMF Analyst will coordinate and support Clinical Operations TMF Quality Control (QC) processes and create and report TMF metrics.

Essential Functions

• Generate, organize, deliver TMF performance metrics for various functional areas.
• Support Trial Operations with the TMF implementation and throughout the study as needed with oversight by the designated Clinical Programs Manager(s) and Clinical Trial Managers CTM(s).
• Perform risk-based periodic reviews of quality issue responses and document quality reviews, as needed, on site, country, or study level or as delegated by Trial Maintenance Management.
• Perform document review for suitability, content, legibility, and conformance with good documentation practices (GDP)
• Respond to or delegate TMF alerts, tasks, and quality issues as TMF Subject Matter Expert (SME)
• Raise quality issues for TMF issues found, as applicable
• Ensure similar documentation issues are handled uniformly across all trials / programs
• Exhibit knowledge of applicable FDA, ICH / GCP guidelines to perform review on documents that have been filed to the TMF and to support inspection readiness goals
• Participate in project specific meetings and educate functional leads in TMF requirements
• Ensure accurate completion and maintenance of TMF.
• Demonstrate ability to make sound business decisions based on evidence (SOPs and guidance documents) and experience, deliver on commitments, share knowledge, acknowledge others achievements, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment
• Performs other duties as assigned

Education & Experience

• Bachelor’s degree with 3+ years of relevant Trial Master File experience (or 6+ years relevant clinical research experience)
• Experience in study start-up, study maintenance and document quality reviews preferred
• Relevant experience in clinical trials related roles (i.e. clinical operations and project management).
• Previous experience with independently managing projects and handling concurrent tasks in a fast-paced environment and delivering results within tight timelines is desirable.
• Experience with eTMF maintenance
• Veeva Vault experience preferred

Knowledge, Skills, & Abilities

• Working knowledge of ICH, FDA, IRB / IEC and other applicable regulations / guidelines; previous interaction with operational project teams preferred
• Ability to adapt to a changing environment and handle multiple priorities
• Detail and process oriented
• Superb organizational and time management skills
• Flexible and adaptable to a developing work environment; willingness to learn
• Positive attitude and approach
• Excellent communication skills, oral and written
• Self-motivation with the ability to work under pressure to meet deadlines
• Works well independently as well as in a team environment
• Interact with internal and external sites and vendors with high degree of professionalism and discretion
• Multi-tasking capability
• Computer proficiency (MS Office - Word, Excel, Power Point), aptitude for training, capable of operating standard office equipment and learning new systems

Working Environment / Physical Environment

• This role will work on-site
• This role primarily works at a computer most of the day

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below.

The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

$28.85 (entry-level qualifications) to $39.00 (highly experienced)

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

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
• We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
30+ days ago