Senior Manager eTMF Operations

Join to apply for the Senior Manager eTMF Operations role at Summit Therapeutics, Inc.

Location: On-site, 4 days per week, available at Menlo Park, CA;
Princeton, NJ; or Miami, FL.

About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving the quality and duration of life for patients with serious unmet medical needs. Summit’s core values are integrity, passion for excellence, purposeful urgency, collaboration, and commitment to people.

• Summit’s Team Is Inspired To Touch And Help Change Lives Through Summit’s Clinical Studies In The Field Of Oncology.
• Summit Has Multiple Global Phase 3 Clinical Studies, including:
• Non‑Small Cell Lung Cancer (NSCLC):
  • HARMONi:
    Phase 3 study evaluating ivonescimab with chemotherapy versus placebo + chemotherapy in EGFR‑mutated, locally advanced or metastatic NSCLC patients previously treated with a 3rd‑generation EGFR TKI.
  • HARMONi‑3:
    Phase 3 study evaluating ivonescimab with chemotherapy versus pembrolizumab + chemotherapy in first‑line metastatic NSCLC.
  • HARMONi‑7:
    Phase 3 study evaluating ivonescimab monotherapy versus pembrolizumab monotherapy in first‑line metastatic NSCLC.
• Colorectal Cancer (CRC):
  • HARMONi‑GI3:
    Phase 3 study evaluating ivonescimab + chemotherapy versus bevacizumab + chemotherapy.

We are looking for an eTMF Manager orting to the Director of TMF, the role encompasses wide‑range responsibilities such as maintenance of overall compliance for ongoing and new studies; assisting in building a culture of inspection readiness; achieving inspection readiness; supporting sustainability and compliance initiatives; and acting as overall Sponsor TMF Lead and Vendor TMF Focal Lead for all Summit‑sponsored studies.

• Help build a culture of Inspection readiness and sustainable compliance initiatives.
• Support the Quality Management System within the Operation Team from a Compliance perspective.
• Work closely with the Line Manager and the wider Operations team in maintaining objectives and an Inspection Readiness culture across the organization.
• Manage the set up and maintenance of electronic Trial Master Files (eTMF) and related artifacts for clinical studies in accordance with TMF processes, working with key study personnel such as the Project Manager.
• Lead the development, creation, and maintenance of the eTMF Plan and TMF Index with Project Manager/Study Lead and/or CROs.
• Responsible for mapping the sponsor’s TMF Index, as applicable, to the Summit TMF.
• Index and add/modify all approved TMF artifacts in the Summit TMF Index, according to Summit SOPs, and/or sponsor SOPs.
• Achieve audit readiness state and then maintain the TMF in an inspection‑ready state.
• Perform visual quality checks of e‑documents prior to release to confirm image clarity and readability.
• Perform Inspection Ready Checks on individual documents uploaded in the eTMF system for every study, ensuring context is accurate.
• Initiate the “What’s Missing” for all documents and reference sections to ensure full completeness of the TMF for each study, tracking and obtaining missing, incomplete, incorrect, inaccurate artifacts against the TMF Plan and study milestones.
• Comply with metrics established for performance TMF reviews.
• Process and track final essential artifacts required throughout all phases of the study in accordance with Summit SOPs, sponsor SOPs, GCP, and ICH guidelines.
• Manage identification of operational and logistical issues and resolutions related to the TMF.
• Gather data requested by the study team to support status reports to clients.
• Prepare the TMF for QA or Sponsor audits; lead the resolution by identifying and implementing corrective actions to findings in audit reports.
• Participate in audits and regulatory inspections by providing guided access to the eTMF study area.
• Review and respond to TMF content quality issues and identify trends per study and across programs; alert management of trends.
• Proactively prepare the TMF study artifacts for export and transfer to the Sponsor at interim points and/or at the end of the study, working with the relevant team members.
• Must be open to collaboration and teamwork within…