Impel NeuroPharma is a late stage pharmaceutical company based in Seattle, WA. We are committed to developing the next generation of central nervous system (CNS) drug treatments. Impel’s proprietary Precision Olfactory Delivery (POD™) technology enables many categories of therapeutics to be delivered to the CNS using consistent and predictable upper nasal drug delivery. We are working hard to create life-changing, innovative therapies for CNS diseases and we hope you’ll join us.
Manager, Trial Master File (TMF)
ACCOUNTABILITY OBJECTIVE:
In this key role, the Manager, TMF is the subject matter expert for activities that ensure contemporary, complete, and accurate Trial Master Files through documentation quality and consistency across clinical trials and programs. The Manager, TMF collaborates closely with the PM or equivalent for all trial master file responsibilities conducted internally as well as externally with Contract Research Organizations (CROs). The Manager, TMF will provide crucial TMF quality support to the Study Team and is expected to establish a proactive quality-focused partner-relationship with the Study Team.
Initial priorities for this position include establishing SOPs (drafting, reviewing, and updating as required). In addition, s/he will facilitate the upload of electronic files to the Impel ECM system, Montrium.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned:
- TMF management/vendor management
- Facilitate the creation of study specific TMF management tools
- Develop and maintain TMF Management Plans, TMF Content Lists/File Plans, TMF Comprehensive Review tracker and TMF-related risk assessments in collaboration with study teams
- Participate in the Quality Control process for documents (paper and electronic) submitted to the TMF or eTMF
- Facilitate the review and submission of TMF records to TMF
- Coordinate or support the coordination of the transfer of study-specific trial master files from the CRO per Impel SOP(s)
- Participate in Study Team meetings and provide/present regular TMF metrics updates: completeness and quality of TMF documentation and content, including the percent completeness and the risk level of outstanding items on a periodic basis or as requested by Impel management
- Maintain awareness of study events and manage the associated documentation requirements, including collection/inclusion, through collaboration with Study Team and 3rd party vendors
- Support Study Teams and designated Study Team Content owners in understanding their TMF-related responsibilities, requirements and expectations
- Act as point person for Study Team TMF questions and manage close-out of TMF related issues
- Support the Study Team in TMF document retrieval during Audits and Inspections (paper and electronic)
- Identify risk(s) associated with TMF process and any corrective actions which must be addressed and assigned
- Support the submission of documented evidence of the TMF Quality Review to the TMF
- Support the management of TMF documentation issues throughout the lifecycle of an assigned study
- Collaborate with Quality Department to support and carry out processes associated with Records Management
- Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to the management of TMF related activities
- Provide guidance on best practices for TMF record handling, retrieval and archival procedures
- Provide archived Impel records to users (e.g. internal staff and/or Auditors) for review
- Oversee the provision of the required documents at the time of Regulatory Authority Inspection or internal Audits
- Respond to TMF internal and/or external information inquiries related to Impel TMF records
- Participate in the development, implementation, and maintenance of TMF classification and filing systems per administrative, research, regulatory, and quality requirements
- Manage and oversee contract vendors for off-site storage/archiving of Impel TMFs
- Support the implementation maintenance of Impel’s eTMF system
- Support /oversee daily Trial Master File management activities such as Review, Processing, Filing of Clinical Trial Master File documents, to ensure the TMF is Inspection Ready of Impel’s eTMF system
EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
- Bachelor’s degree preferred
- A minimum of 5 years of experience working within the TMF (includes CRO / Vendor experience)
- 2 plus years Pharma experience (includes CRO / Vendor experience)
- Strong knowledge ICH/GCP documentation requirements
- Experience with eTMF systems, preferably Montrium Connect and Veeva Vault
- Experience with managing clinical study documentation
- High attention to detail
- Excellent organizational skills
- Experience with MS Office
- Excellent verbal and written communication skills
- Able to demonstrate a flexible, proactive, diligent and self-motivated approach to work
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions.
WORKING CONDITIONS
This is a fast-paced environment with moderate noise level. Limited travel may be required.