Trial Master File (TMF) Manager

Oruka Therapeutics • Waltham, MA

3h • Hybrid

About The Position

As a Trial Master File (TMF) Manager, you will be responsible for acting as a central contact for the Clinical Study Teams for Trial Master File (TMF) management and participating in the development of quality oversight processes for TMF management of Oruka’s clinical trials. Additional responsibilities include the review, and approval of TMF documents, co-authoring and managing TMF documents such as TMF Plan, Index, SOPs, and other guidance documents and ensuring quality management by reporting TMF metrics, periodic checks of adherence to SOPs, and reconciling all outstanding queries and issues (e.g., CAPAs). Support Clinical Operations Management in high-level projects, developing processes, strategies and conducting training for TMF stakeholders. Responsible for overseeing the activities of the external vendors, ensuring that study documents are adherent with ICH-GCP guidelines, other regulatory requirements, and internal and external standard operating procedures (SOPs) and that their assigned studies are inspection-ready.

Requirements

• RN or bachelor’s or master’s degree desired.
• Minimum of 8+ years working in a pharmaceutical or other highly regulated corporate environment.
• Strong experience collaborating with the DIA (CDISC) TMF Reference Model.
• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.
• Strong experience in Trial Master File requirements and set up.
• Strong knowledge of electronic document management systems, document archival systems: (eTMF) and CTMS systems.
• A clear understanding of the clinical development lifecycle and the technologies associated with the activation and management of clinical trials and study sites.
• Ability to successfully oversee study TMFs including development of relevant processes and policies.
• Experience in selection of CROs/vendors and management of external resources.
• Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Excellent written/verbal communication and people skills.
• Strong decision-making skills.
• High sense of priority and commitment to excellence in the successful execution of deliverables.
• Ability to analyze operational data, contribute with a mindset focused on quality, timeliness and fiscal responsibility, drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of the Clinical Operations Process and Systems team.
• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

Responsibilities

• Adhere to Clinical Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines
• Be a primary lead with eTMF and CTMS integration/implementation/maintenance, user training, team advisor and assist in managing oversight for the RevMed clinical trial TMFs and CTMS within timelines and designated program budgets.
• Provide strong support to establish and manage quality oversight of TMF and CTMS, including TMF metrics and KPIs.
• Partner with Clinical Study Teams, CROs/vendors and cross-functional team members to align TMF activities, as needed.
• Responsible for vendor and internal implementation and maintenance process for cataloging, filing, retrieving, storing, preserving, and protecting CTMS outputs and TMF records (paper and electronic).
• Develop successful working relationships with service providers (vendors) and CROs on TMF management including review process, ensuring TMF completeness and managing the transfer for TMF records as needed.
• Provides TMF SME audits and inspections support.
• Contributes to and implements TMF planning and strategy development, which may include evaluation of possible options for on and off-site locations.
• Use all available tools to track, analyze, oversee, and report CTMS and TMF health metrics and status to all key stakeholders.
• May be responsible for direct TMF management activities, e.g., for assigned study TMF(s)
• Responsible for contributing to risk management, contingency and scenario planning.
• Analyze and report TMF health metrics by study to be shared with stakeholders.
• Supervise, communicate system status, issues and problem solves to ensure project team goals are met.
• Actively contribute to the selection and management of eTMF, CTMS and other Clinical System solutions / vendors, including development of Requests for Proposals (RFPs)
• Anticipate obstacles, difficulties, be solution-oriented, proactively provide risk assessment and mitigation strategies to achieve goals.
• Participate in and/or co-lead departmental or interdepartmental strategic business initiatives, as well as contribute to SOP development, implementation, and training.

Benefits

• Competitive salary and benefits package.
• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree
• Number of Employees: 1-10 employees