Senior Manager eTMF Operations

Summit Therapeutics Plc•Menlo Park, CA

1d•Onsite

About The Position

Senior Manager eTMF Operations Department: Clinical Operations Location: Princeton, NJ Location: On-Site 4 days per week at our Menlo Park, CA, Princeton, NJ or Miami FL locations About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. 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 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: We are looking for an eTMF Manager at Summit. Reporting to the Director TMF, the role encompasses a wide range of responsibilities such as, but not limited to: maintenance of overall compliance for the ongoing and new studies; assistance in building a culture of inspection readiness; to work towards achieving inspection readiness; to help assist in sustainable compliance initiatives, and to act as overall Sponsor TMF Lead and Vendor TMF Focal Lead for all summit-sponsored studies.

Requirements

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).
Knowledge of Investigator Site File, Site monitoring and maintenance other study documents are 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

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