Senior Specialist, 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 Senior Manager, eTMF, you will be an integral contributor to MapLight's Trial Master File (TMF) quality, compliance, and inspection readiness. You will contribute to the management and support of MapLight's eTMF, including start-up activities, document filing, document review, and quality checks (QC), ongoing quality and completeness reviews, and close-out activities. Collaborates with the clinical study team to set up, manage and oversee the study TMF to ensure quality deliverables.

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

Responsibilities:

• Set up study eTMF in accordance with study requirements.
• Support document filing in MapLight's internal eTMF.
• Support TMF Quality in accordance with MapLight SOPs and regulatory requirements (ICH GCP).
  • Create study-specific TMF Plans and Maps to align with system usage and TMF quality requirements in collaboration with CROs and vendors.
  • 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 QC of the study TMFs as outlined in study TMF Plans and escalate risks and/or issues related to TMF quality to the study team.
  • Ensure overall TMF completeness with MapLight's functional groups, CROs, and vendors.
  • Monitor TMF metrics for compliance (e.g., document processing times)
  • Escalate TMF quality issues and drive resolution of required CAPAs and/or process improvement, as applicable.
• Review documents submitted to eTMF for suitability and quality.
• Generate and oversee resolution of TMF findings related to QC, completeness reviews, audits, and inspections.
• Act as eTMF SME at study Kick-off meeting and Investigator meetings (CRA training) and attend regular study team meetings to report on the status of the TMF.
• Support the study teams to ensure study TMFs are submission and inspection ready at all times.
• Support the implementation, configuration, and maintenance of MapLight's eTMF system.
• Lead TMF migration activities including generating the TMF Migration Plan, pre and post migration QC, and generation of relevant documentation for the migration.
• Lead TMF Archival Activities, as assigned.
  • 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.
• May act as TMF SME during regulatory inspections or audits.
• Assist with TMF process development and process improvement.
• Other such duties as requested or assigned.
• Embody and demonstrate MapLight's core values of Integrity, Collaboration, Bravery, and Dedication.

Qualifications:

• Minimum of 3 years of experience managing TMF activities to support clinical studies.
• Experience managing multiple TMFs in paper, electronic, and hybrid format, with process consistency, quality, and in compliance with regulatory requirements.
• Deep understanding of clinical trial documents and industry standard TMF Reference Model and requirements for processing documentation into the eTMF system.

• Strong working knowledge of the drug development process, Good Clinical Practices (GCPs), ALCOA+, and pertinent regulations.

• Working knowledge of international regulatory and ethics record requirements.
• Working knowledge of relevant global privacy regulations.
• Experience with TMF archiving and global 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.
• Experience managing TMF documents and eTMF systems during regulatory inspection is preferred.

• Experience with implementation, validation, management, and change control for eTMF systems preferred.

• Strong attention to detail and focus on quality and compliance in all aspects of assigned work.

• 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.

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.