What are the responsibilities and job description for the Trial Master File (TMF) Manager position at Kiniksa Pharmaceuticals?
eporting 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.
This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
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 :
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.