Careers

Senior Manager, eTMF

Who We Are:

MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.


What You’ll Do:

Reporting to the Director, Monitoring Strategy and Execution, you will be an integral contributor to MapLight’s Trial Master File (TMF) quality, compliance, and inspection readiness program. You will co-own MapLight’s internal eTMF system and support its management, access, maintenance, and oversight.  You will participate in system configuration and change controls. You will also be responsible for the development of training materials and training users at all levels, internal and external.  You will be responsible for all aspects of archiving each of MapLight TMFs.

This role will collaborate closely with cross-functional teams in quality assurance, clinical operations, data management, regulatory affairs, and others to support compliant records retention and inspection readiness.


Responsibilities:

  • Contribute to the implementation, configuration, and maintenance of MapLight’s eTMF system.
    • Participate in eTMF implementation and configuration as a subject matter expert.
      • Recommend configurations, workflows, and features that support quality and oversight of the TMF.
    • Contribute to the development of SOPs, plans, forms, and training tools to support implementation, maintenance, and use of MapLight’s eTMF.
    • Collaborate with eTMF vendor managed services personnel to support periodic system maintenance and drive continued process improvement.
    • Liaise with user stakeholders to understand how the eTMF is being used and opportunities for improvements.
      • Drive process improvements in system configuration or revision to process documents.
    • Build and manage reports and dashboards, as needed.
    • Oversee relevant change controls to support configurations or system releases in collaboration with quality assurance.
      • Outline and manage change plans in MapLight’s QMS.
      • Perform validation exercises in accordance with change plans.
      • Update procedural documents and training materials in alignment with change controls and new configuration.
      • Develop training plans as needed to ensure users are made aware of new or revised system features.
    • Manage User access and training.
      • Provide training and access for system users.
      • Serve as a resource for users to answer questions or provide re-training.
    • Oversee TMF Quality in accordance with MapLight SOPs and regulatory requirements (ICH GCP).
      • Support the development of study TMF Plans to align with system usage and TMF quality requirements.
      • Liaise with core study team members to secure alignment on study specific TMF processes.
        • Roles and responsibilities for filing and document QC.
        • TMF quality checks and completeness/content reviews.
      • Perform routine quality checks of the study TMFs as outlined in study TMF Plans and escalate risks and/or issues related to TMF quality to the study team.
    • Serve as MapLight’s TMF Archivist for all TMFs.
      • For CRO managed TMFs transferred to MapLight, perform pre-archival QC prior to or following transfer as outlined in the study TMF plan and complete all documentation required for archival.
      • For TMFs in MapLight’s eTMF, perform pre-archival QC prior to archival, complete all archival documentation, and archive the TMF in MapLight’s eTMF.
      • Support study teams in archiving the TMFs.
    • Act as the MapLight eTMF SME during regulatory inspections or audits.
    • Perform other assigned TMF related tasks, as requested.
    • Embody and demonstrate MapLight’s core values of Integrity, Collaboration, Bravery, and Dedication.


Qualifications:

  • At least 5 years of experience in Clinical Research at an Investigator site, sponsor or CRO. At least 3 years’ experience in clinical research document management at a sponsor or CRO.
  • Experience with GxP system implementation, configuration, validation, and maintenance preferred.
  • Experience developing TMF related SOPs, templates, plans, and tools.
  • Experience managing multiple TMFs with process consistency, quality, and in compliance with regulatory requirements.
  • Experience with TMF archiving and records retention requirements for clinical trials. This includes preparing a TMF for archival, executing final quality checks, working with internal and external stakeholders to resolve findings, and completing documentation for TMF archival.
  • Deep understanding of clinical trial documents and industry standard TMF Reference Model.
  • Strong working knowledge of Good Clinical Practices (GCPs), ALCOA+, and pertinent regulations.
  • Ability to engage collaboratively with internal and external stakeholders in a professional manner.
  • Strong interpersonal, oral, and written communication skills.
  • A self-starter with the ability to work independently and proactively.
  • High attention to detail and focus on quality and compliance in all aspects of assigned work.


Travel:  Position will require periodic travel for meetings (up to 10%).

 

MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

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