Trial Master File (TMF) Manager

Reporting to the Senior Director, Clinical Operations, the Trial Master File (TMF) Manager will support high quality TMFs across Kiniksa’s ongoing and completed clinical studies with adherence to ICH-GCP guidelines, other regulatory requirements, and standard operating procedures (SOPs). The TMF Manager plays a critical role in ensuring the completeness and accuracy of the TMF for all assigned Kiniksa-sponsored clinical trials. The TMF Manager will support multiple clinical studies simultaneously with both Kiniksa-hosted and CRO-hosted TMFs.

Responsibilities (including, But Not Limited To)

• Collaborate with clinical operations manager, clinical study teams, and CRO to ensure a high level of quality and maintain compliance of TMF through the study life cycle
• Monitor operational metrics to support oversight of the TMF
• Conduct contemporaneous oversight TMF reviews and close out TMF reviews
• Author and/or contribute to development of initial TMF plan and updates throughout the trial
• Support study setup, including development of Expected Documents Lists, and archival/transfer as required
• Identify TMF risks and ensure compliance with internal and regulatory requirements
• Respond to inquiries regarding TMF management and contents
• Run routine TMF reports and monitor TMFs for completeness and trends, and drive actions when issues or negative trends are identified
• Oversee TMF user access management as required
• Ensure TMF inspection readiness
• Support inspection and audit preparation and execution (front and back room as needed)
• Support system updates by participating in user acceptance testing and system enhancement discussions
• Support innovative process improvements as the TMF subject matter expert
• Manage CRO TMF personnel
• May manage TMF contractors or internal TMF Specialists
• Attend departmental and trial-specific meetings and discussions, as required
• Complete other TMF document-related tasks as required
  
  

Qualifications

• 5+ years of relevant clinical research record management experience in a pharmaceutical, academic, or CRO environment
• Bachelor's degree or equivalent education in life sciences, record management, public health management, or related fields
• Experience with electronic TMF systems and technologies, Veeva Vault experience required
• Solid understanding of the clinical trial process; Experience in handling clinical trial related documents required and knowledge of Trial Master File Reference Model Structure standard
• Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management
• Demonstrated ability to understand and comply with ALCOA+ standard, Good Clinical Practice (GCP), Good Documentation Practices, and International Council for Harmonization (ICH) E6(R2) guidelines
• Experience in managing multiple projects and coordinating with cross-functional teams
• Ability to prioritize, manage, organize, and maintain large amounts of documentation, both electronic and paper
• Ability to identify and manage risks and resolve issues in a timely manner
• Skilled at problem-solving and proposing solutions
• Ability to work independently with minimal direction/oversight
• Effective communication and interpersonal skills
• Strong organizational skills with outstanding attention to detail and follow through
• Strong commitment to compliance and ethical standards
• Proficient in the use of Microsoft Office and SharePoint, advanced skills in Excel highly desirable
• Salary is commensurate with experience
• Kiniksa Benefits Summary - USA
  
  

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.