Summit Therapeutics, Inc.
Senior Manager eTMF Operations
Summit Therapeutics, Inc., Menlo Park, California, United States, 94029
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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.
Overview Of Role We are looking for an eTMF Manager at Summit. Reporting 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.
Role And 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 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 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 audits to ensure they are satisfactorily closed within the committed time frame.
Support tasks deemed appropriate by the Line Manager.
All other duties as assigned.
Experience, Education And Specialized Knowledge And Skills
A bachelor degree in life sciences or a related field is preferable.
Minimum 6+ years experience within Clinical Operations.
Minimum 2+ years experience in maintaining and/or handling eTMF (experience with maintaining eTMF within Veeva Vault is preferred).
Knowledge of Investigator Site File, site monitoring and maintenance of other study documents 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.
Pay Range:
$158,000 - $185,000 annually. Compensation packages are based on skill set, experience, certifications, and specific work location. The total compensation package may also include bonus, stock, benefits and/or other variable compensation.
Summit does not accept referrals from employment businesses or agencies. All employment businesses/agencies must obtain prior written authorization from Summit’s Talent Acquisition team (recruiting@smmttx.com) before referring any candidates.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Strategy/Planning and Information Technology
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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.
Overview Of Role We are looking for an eTMF Manager at Summit. Reporting 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.
Role And 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 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 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 audits to ensure they are satisfactorily closed within the committed time frame.
Support tasks deemed appropriate by the Line Manager.
All other duties as assigned.
Experience, Education And Specialized Knowledge And Skills
A bachelor degree in life sciences or a related field is preferable.
Minimum 6+ years experience within Clinical Operations.
Minimum 2+ years experience in maintaining and/or handling eTMF (experience with maintaining eTMF within Veeva Vault is preferred).
Knowledge of Investigator Site File, site monitoring and maintenance of other study documents 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.
Pay Range:
$158,000 - $185,000 annually. Compensation packages are based on skill set, experience, certifications, and specific work location. The total compensation package may also include bonus, stock, benefits and/or other variable compensation.
Summit does not accept referrals from employment businesses or agencies. All employment businesses/agencies must obtain prior written authorization from Summit’s Talent Acquisition team (recruiting@smmttx.com) before referring any candidates.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Strategy/Planning and Information Technology
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