Senior Trial Master File (TMF) Specialist

Overview

Iovance seeks an experienced and highly motivated Senior, Trial Master File (TMF) Specialist to join our organization. As a Senior Trial Master File (TMF) Specialist, you will play a critical role in managing and optimizing our clinical trials’ eTMFs/pTMFs/TMFs. You will be responsible for providing subject matter expertise to functional areas within the organization, for ensuring the eTMF is audited, and inspection always readied, ensuring the eTMF is managed in accordance with relevant regulations, ICH-GCP guidelines, and Iovance SOPs. A successful candidate will possess a strong background in Clinical Trial Documentation, excellent proactive and leadership skills, and a passion for enhancing and optimizing clinical trial operations through the effective management of clinical trial documentation systems and processes.  

Essential Functions and Responsibilities

·       TMF Operations Clinical Study Oversight: 

• Act as the single-point-of-contact at IOVANCE for all eTMFs 
• Serve as subject matter expert on domestic/international documentation requirements. 
• Maintenance and management of overall eTMF operations including coding and filing of all study documents per DIA model structure  
• Evaluate study requirements; ensure appropriate eTMF structure is developed prior to start-up 
• Ensure the eTMF is maintained with an audit-ready strategy 
• Lead periodic file completeness review throughout the life of the assigned studies.  
• Develop and distribute eTMF status updates to IOVANCE Clinical Trial Managers and CRAs for CRO follow-up and resolution 
• Address identified discrepancies noted in status reports and resolved within timelines designated in TMF plan 
• Coordinate interim, and close-out eTMF audits with Clinical QA 
• Participate in audits and/or inspections of Clinical Operations and the eTMF 

·       TMF Process Efficiency & Operational Excellence: 

• Assist in developing eTMF-related SOPs, working practices, and forms, as needed, to ensure compliance with ICH E6(R2) 
• Identify opportunities for continuous process improvement; recommend solutions. 
• Participate in eTMF vendor search and selection 
• Collaborate with cross-functional teams to identify opportunities for improvement, advancement and development of the TMF Culture at Iovance.  

·       Vendor Relationship management:  

• Serve as Point-of-Contact for assigned studies’ eTMFs for any questions that may arise between the Clinical Service Provider (e.g., CRO) and Iovance 
• Lead discussions with the Clinical Service Provider to determine the best strategy for managing quality oversight of assigned trial master files  
• Escalate issues to the Senior TMF Manager 

·       User Administration, Support and Training 

• Ensure document quality and compliance through active engagement with clinical study teams and management 
• Support training of Clinical Development personnel on the eTMF solution and relevant SOPs 
• Ensure Clinical Development personnel are appropriately assigned eTMF User roles and permissions 
• Ensure compliant user onboarding, regular review, and offboarding 
• System Upgrades and Changes: 
• Lead the specification, configuration, migration, UAT and implementation of the eTMF solution 
• Support change management activities to support implementation, and updates of system changes
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Travel

·       Able to attend off-site meetings/training/conferences as needed 

Required Education, Skills, and Knowledge

• Minimum of 8 years of experience with a bachelor’s degree; or 6 years with a Master’s degree; or 3 years with a PhD of progressively responsible experience in a pharmaceutical, biotechnology or related environment in roles focused clinical trial documentation, clinical trial documentation system oversight, and inspections/audits.  
• Proficiency with eTMF technology including prior, demonstrated experience managing eTMF systems and/or service providers is required 
• Experience with Veeva Vault eTMF software is highly desirable 
• Associates/bachelor’s degree in a relevant discipline preferred 
• Experience with the CDISC Trial Master File Reference model and a demonstrated understanding of records management best practices 
• Demonstrated understanding of the clinical drug development process and clinical trial methodology 
• Demonstrated current knowledge of ICH, GCP and other regulatory guidance as applicable to management of clinical documentation 
• Demonstrated ability to assess current and future business needs to ensure the clinical documentation function is strategically and operationally positioned to properly support the Clinical Operations, Regulatory Affairs and Clinical QA 
• Demonstrated leadership ability 
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members 
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects 
• Experience leading and/or contributing to the selection and/or implementation of an electronic eTMF 
• Knowledge of ICH-GCP guidelines in relation to TMFs 

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time. 
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.  
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice. 

#LI-remote