Senior Manager eTMF Operations

Role Summary

Senior Manager eTMF Operations responsible for maintaining compliance and inspection readiness of eTMF for Summit-sponsored studies, acting as Sponsor TMF Lead and Vendor TMF Focal Lead. Reports to the Director TMF. This role requires collaboration across cross-functional teams and focuses on building a culture of inspection readiness and sustainable compliance initiatives. Location: On-Site 4 days per week at Menlo Park, CA, Princeton, NJ, or Miami, FL.

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 Inspection Readiness across the organization.
• Manage the setup 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, creation and maintenance of the eTMF Plan and TMF Index with Project Manager/Study Lead and/or CROs.
• Map the sponsor's TMF Index to the Summit TMF as applicable.
• Index and modify TMF artifacts in the Summit TMF Index according to Summit SOPs and sponsor SOPs.
• Achieve audit readiness and 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 documents uploaded in the eTMF system for every study, ensuring context is accurate.
• Initiate ‚ÄúWhat‚Äôs Missing‚Äù for all documents and reference sections, tracking and obtaining missing or incomplete artifacts against the TMF Plan and milestones.
• Adhere to metrics established for TMF performance reviews.
• Process and track final essential artifacts throughout all study phases in accordance with SOPs, GCP, and ICH guidelines.
• Identify and resolve operational and logistical issues 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 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; alert management of trends.
• Prepare TMF study artifacts for export/transfer to Sponsor at interim points or study end, in collaboration with relevant team members.
• Collaborate within cross-functional teams and participate in business improvement initiatives to drive quality and continuous process improvement.
• Maintain understanding of applicable regulatory requirements and attend internal/external study team meetings as required.
• Perform other related duties as assigned and support drafting/review/approval of documents using Summit systems.
• Assist in progress of documents to ensure review/approval within cycles and closure of audit action items within timeframes.

Qualifications

• Required: Minimum 6+ years of experience within Clinical Operations.
• Required: Minimum 2+ years of experience in maintaining and/or handling eTMF (experience with Veeva Vault preferred).
• Required: Knowledge of Investigator Site File, Site monitoring and maintenance of study documents (preferred).
• Required: Demonstrated commitment to Quality and Compliance (Big Picture Approach).
• Required: Excellent communication skills and ability to liaise with colleagues and system providers.
• Required: Proven ability to adapt, prioritize, and maintain strong organizational skills; ability to work independently and as a strong team player.
• Required: Effective communication of complex ideas in an understandable way; ability to prioritize conflicting demands; ability to work in a fast-paced environment.
• Preferred: Bachelor degree in life sciences or related field.
• Preferred: Experience leading TMF activities and coordinating with CROs or external partners.

Education

• Bachelor degree in life sciences or related field is preferable.

Skills

• Quality and Compliance mindset with attention to detail.
• Strong organizational and project management abilities.
• Effective stakeholder engagement and cross-functional collaboration.
• Proficiency with electronic TMF systems (e.g., Veeva Vault) and TMF indexing.
• Knowledge of GCP, ICH guidelines applicable to TMF.