Summit Therapeutics, Inc. · 3 days ago
Senior Manager eTMF Operations
Menlo Park, CA
Full-time
Onsite
Senior Level
$158K/yr - $185K/yr
6+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing serious unmet medical needs. They are seeking a Senior Manager eTMF Operations to oversee compliance for clinical studies, manage electronic Trial Master Files, and ensure inspection readiness while collaborating across teams.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
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 the objectives (and key results) and Inspection Readiness culture across the organization
Manage the set up and maintenance of electronic Trial Master Files (eTMF), Trial, Country and Site artifacts) for clinical studies in accordance with TMF processes, working with key study personnel such as the Project Manager
Lead the development, create and maintain the eTMF Plan and TMF Index with Project Manager/Study Lead and/or CROs
Responsible for mapping the sponsors 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
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 ensuring 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 the identification of operational and logistical issues and resolutions related to the TMF
Responsible for gathering 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 cross-functional teams
Participate in business improvement initiatives to drive quality, productivity, and continuous improvement of business processes
Maintain an understanding of applicable regulatory requirements
Attend internal or external study team meetings as required
Perform other related duties as assigned
Support other functions in drafting, reviewing, and approving documents / records using Summit approved or authorized electronic systems
Assist in the progress of documents ensuring that documents are reviewed and approved within the review cycle
Assist in the progress of action items as indicated in any internal or hosted audits to ensure they are satisfactorily closed within the committed time frame
Support in any other tasks as deemed appropriate by the Line Manager
All other duties as assigned
Qualification
Required
A Bachelor degree in life sciences or related field is preferable
Minimum 6+ yrs experience within Clinical Operations
Minimum 2+ yrs experience in maintaining and/or handling eTMF (experience with maintaining eTMF within Veeva Vault is preferred)
Demonstrated commitment to Quality and Compliance (Big Picture Approach)
Excellent communication skills, liaising with colleagues and system providers
Proven ability to change, prioritize accordingly and maintain strong organizational skills
A willingness to be flexible, performing responsibilities not identified in this role specification, and assuming responsibilities as our needs change
Must have the ability to work independently and demonstrate a good team player, with proven ability to provide practical and pragmatic solutions with speed and efficiency
Communicate effectively and articulate complex ideas in an easily understandable way
Prioritize conflicting demands
Work in a fast-paced, demanding and collaborative environment
Preferred
Experience with maintaining eTMF within Veeva Vault is preferred
Knowledge of Investigator Site File, Site monitoring and maintenance other study documents are preferred
Benefits
Bonus
Stock
Benefits
Other applicable variable compensation
Company
Summit Therapeutics, Inc.
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.
201-500 employees
H1B Sponsorship
Summit Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.79BKey Investors
CARB-XEurofarmaBiomedical Advanced Research and Development Authority (BARDA)
2025-10-21Post Ipo Equity· $500M
2024-09-11Post Ipo Equity· $235M
2024-06-03Post Ipo Equity· $200M
Leadership Team
Manmeet Soni
Chief Operating Officer and Board Member
Recent News
2025-12-09
2025-12-05
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