Trial Master File (TMF) Manager, Clinical Operations

Job Description

Job Description

Trial Master File (TMF) MANAGER, Clinical Operations

Company Overview:

Mythic Therapeutics is a privately held, clinical stage product-platform company building a pipeline of best-in-class antibody drug conjugates (ADCs) exhibiting a combination of unprecedented efficacy and therapeutic index. The Company’s FateControl™ engineering technology dramatically enhances ADC uptake in tumor cells with less impact on healthy cells, thereby safely increasing efficacy and opening up new therapeutic opportunities against a broad array of tumor targets.

At Mythic Therapeutics, we approach our work as entrepreneurs and innovators, blazing new trails that lead to better patient outcomes. We do so decisively and thoughtfully, drawing upon the decades of experience within our leadership team and scientific advisers. If you share our passion and sense of urgency for developing effective cancer treatment options and are looking for a dynamic, collaborative, and fulfilling work environment, we invite you to explore opportunities to join our team. Together, we are re-envisioning cancer therapy.

Job Summary:

Mythic Therapeutics is searching for a dynamic Trial Master File (TMF) Manager, Clinical Operations to join our growing Clinical Development team. This person will be responsible for maintaining the Trial Master Files (TMFs) to ensure they are current and ready for inspection by internal and external entities. This role requires a strong understanding of clinical trial conduct, TMF structure, eTMF systems, and best documentation practices. The ideal candidate will lead the management of clinical documents and support Clinical Operations Study Leaders in overseeing eTMF. They will work with a wide array of internal and outsourced development functions including but not limited to; project management, site monitoring, medical writing, biostatistics, data management, clinical supplies, finance, and document management. The ability of this person to build strong relationships both internally and externally will be critical to the success of this role. This role reports to the Director, Clinical Operations.

Key Responsibilities and Opportunities:

• Manage clinical document quality, control, filing, and the Trial Master Files (TMFs).
• Perform setup activities, document filing, and oversight of internal eTMF applications.
• Support Clinical Operations Study Leaders in the quality control and oversight of CROs' and internal eTMF applications.
• Act as the functional lead for specified e/TMF platform with vendors.
• Provide support and guidance to CROs and support staff for accurate and timely eTMF filing and maintenance according to ICH GCP guidelines.
• Provide training to eTMF users and external parties (CROs, vendors).
• Collaborate with management and others to support functional and organizational initiatives, driving new procedures and ideas.
• Support the development and review of standard operating procedures and work instructions related to clinical document management.
• Create and maintain written instructions, SOPs, guidelines, and plans related to eTMFs and document control.
• Update and maintain Naming and Filing Guide(s) for relevant e/TMF systems.
• Work in collaboration with all applicable functional areas and Clinical Operations to drive new procedures and processes.

• Build and maintain solid professional relationships with the internal team, CROs/vendors, investigators, and clinical study site staff
• Participate in SOP, work instruction and template development and improvement initiatives
• Support internal audits and regulatory inspections, as needed.

Minimum Requirements

• Bachelor’s degree in life sciences or equivalent training required
• Minimum of two (2+) years of experience in global clinical operations/development in a CRO or bio-pharma setting with a minimum of 5 years of direct TMF management experience.
• Experience managing the TMF for Global Phase 1-3 Oncology Clinical Trials is preferred
• A track record of effectively working with and influencing cross functional team members to ensure adherence to GCP and regulatory requirements
• Demonstrated understanding of clinical trial related documentation.
• Experience with eTMF system or software, including development of SOPs, user training manuals, performing UATs and validations.
• Experience supporting or participating in GCP inspections (e.g., FDA, EMA, MHRA) preferred.
• Understanding of global regulatory requirements and guidelines for conducting clinical research in accordance with FDA, EMEA, ICH, GCP and other applicable regulations and guidelines
• Exceptional organizational skills and ability to deal with competing priorities
• Excellent verbal and written communication

• Ability to travel up to 10%

• Comfortable working with MS Office and project management software (MS Word, Excel, PowerPoint, MS Project, Smartsheet, or similar)

Personal Characteristics and Cultural Fit:

• Good judgement : Strong problem solving, critical thinking and analytical skills required to make evidence-based decisions. Good judgment, level-headed, neutral, and objective.

• Builds Relationships and Culture : Reputation for creating strong team cultures of quality, trust, and collaboration. Skilled at building and managing relationships cross-functionally and with external collaborators/partners, consultants, and vendors.

• Influences : Highly credible with various stakeholder group (internal employees up-down and across the organization, external collaborators, partners, and vendors and with site teams and investigators). Skilled at building and cultivating stakeholder confidence.

• Execution mindset: Self-starter with a can-do mindset and do what is needed to advance the company’s programs and initiatives. Drives self, individual and team accountability, develops and implements goals, objectives, measurable targets, and processes to achieve results.

• Demonstrated ability to work in a fast-paced, innovative biotech environment.

Mythic Therapeutics offers a fast-paced, entrepreneurial, team-focused work environment. We also offer a top-notch benefits package and work/life integration. Being part of the Mythic team allows you to become part of a small team that supports professional development while working together to meet the company goals.

Mythic Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Mythic does not accept unsolicited resumes from any source other than directly from candidates.