Senior Manager, Trial Master File (TMF)

Overview

We are seeking an experienced and organized Trial Master File (TMF) Manager to oversee and lead the development and management of Iovance TMF. The TMF Manager serves a key role, working across the business for the execution of TMF Operations processes and strategy. 

The TMF manager will provide tactical support and strategic guidance on TMF processes, filing conventions, index creation, maintenance, and other TMF related matters. TMF manager to ensure Iovance’s compliance with applicable regulatory requirements. As the TMF Manager, you will play a pivotal role in creating and maintaining consistency across studies and programs to ensure essential trial documents are appropriately collected, indexed, stored and accessible, while adhering to regulatory and company standards. As required, you will also roll-up your sleeves to drive and conduct TMF remediation efforts, inspection readiness activities, audits, and inspections. 

Essential Functions and Responsibilities

• Lead the development, implementation, and evolution of Iovance cross-functional TMF SOPs, procedures, training, CRO partnering agreements, and best practices.
• Support TMF systems implementation and consistent organizational use. This may involve hands-on participation in the configuration and maintenance of the TMF systems and development of TMF Management plan(s).
• Ensure TMF project documentation is maintained to the highest level of quality, accuracy, completeness, and compliance with regulations.
• Implement/Maintain TMF quality control processes aligned to GCP, company standards, and regulatory requirements.
• Identify, gather, empower and oversee a team of internal/external SMEs responsible for the collection, tracking, and filing of trial-related documents in the TMF.
• Lead and/or support TMF creation, maintenance, closure, as well as TMF transfer, migration, and integration activities per company and/or CRO SOPs and standards.
• Drive and oversee clinical trial teams and CRO partners in timely filing of documents throughout the trial lifecycle.
• Ensure accuracy, completeness, and quality of TMF content by driving, overseeing, and facilitating regular reviews and audits.
• Provide process/planning and tactical support for TMF-related remediation as needed.
• Lead team in development of TMF training processes and providing guidance/training to team members and stakeholders on TMF expectations, tools, procedures and compliance requirements. 
• Act as the primary point of contact for TMF-related queries, both internally and externally, and liaise with vendors, if applicable.
• Serve as the SME for TMF during Inspections and audits; collaborate with inspection readiness teams and regulatory authorities on TMF-related inquiries and inspections.
• Drive and lead the development of metrics to assess the completeness and quality of the TMF and effectively communicate status updates to the study team and department management. Work with external partners and study team to address gaps, issues and mitigate risks.
• Lead meetings to escalate trends, issues, and establish standards, while problem-solving and seeking appropriate endorsement across study teams/functions. Communicate ideas, solutions, standards.
• Stay updated with industry trends and evolving regulatory requirements related to TMF management, providing recommendations for process enhancements.
• Lead projects in support of study or portfolio TMF objectives and attend standing cross functional meetings.
• May manage or mentor staff members.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

• Perform miscellaneous duties as assigned.

Travel

• May be required to travel for team meetings and other events as needed.

Required Education, Skills, and Knowledge

• Bachelor's degree in a related field (Life Sciences, Healthcare, or similar).
• Proven experience in clinical trial management
• 9 years of relevant industry experience
• 5 years of Trial Master File experience
• Strong knowledge of regulatory guidelines (e.g., ICH-GCP, FDA, EMA) pertaining to TMF.
• Experience with electronic document management systems (eTMF) and related software.
• Proven ability to lead and drive collaboration in a fast-paced, cross-functional team environment.
• Excellent relationship-building, organizational, leadership, and communication skills.

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 or remote office environment and requires operating standard office equipment and keyboards. 

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. 

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