Trial Master File Manager

Role Overview

• 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.

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.

Tech Stack

• Google Cloud Platform

Benefits

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