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Clinical Operations Document Manager

2 months ago

Redwood City, United States Rezolute, Inc. Full time

Company Description

  • Rezolute is a late stage clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance.
  • Rezolute is preparing to initiate a global Phase 3 trial for their lead clinical asset, RZ358, which is a potential treatment for Congenital Hyperinsulinism (CHI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas.
  • The company’s second clinical-stage asset, currently in Phase 2, RZ402, is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME)
  • More information can be found at rezolutebio.com


Responsibilities:

  • Serve as primary eTMF contact for all clinical studies, ensuring questions related to eTMF items are addressed in a timely manner
  • Serve as the Records Manager for eTMF (electronic Trial Master File) lifecycle by performing set-up, quality review, ensuring all documents are accurately uploaded and properly indexed, compliance improvement, archiving
  • Drive creation of eTMF Plans and study-specific Master Lists to oversee execution of study TMF plans
  • Ensure all clinical study documentation is collected, handled, transferred, stored and/or entered into Rezolute’s eTMF in accordance with Standard Operating Procedures (SOPs), ICH-GCP guidelines, and global standards and requirements
  • Report to the Clinical Operations Director and collaborate with the Clinical Operations Team to develop and maintain study TMF Plans and Indexes
  • Monitor and identify study-specific eTMF trends and communicate to Clinical Operations and/ or other functional teams as needed
  • Lead eTMF kick-off meeting for new studies, ensuring roles are assigned as per SOP and relevant study plans
  • Review and update existing eTMF user roles bi-annually or as needed
  • Apply knowledge of the DIA TMF reference model to revise and update study specific Master List templates and Naming Conventions
  • Liaise with study PM during Inspection readiness activities to identify missing documents and identify remediation strategy to obtain missing documents
  • Support mock inspections and act as inspection TMF SME for assigned studies
  • Prepare for Inspection Readiness activities including conducting TMF gap analysis activities on a regular and ongoing basis
  • Act as part of core inspection team to own key responsibilities including document requests, access to the TMF for the auditors and inspectors, and ensuring easy retrieval of clinical documents on request
  • Contribute to the integrity, completeness, and accuracy of Rezolute’s eTMFs
  • Continuously work in a team environment, including meeting deadlines, prioritizing, and balancing work and projects from multiple sources
  • Assist the clinical operations team with activities outside of eTMF with creating any user friendly document formats for agendas, actions items, timelines, or process work flows, as needed


Qualifications:

  • Bachelor of Science with 7+ years of relevant experience in biotechnology/pharmaceutical industry
  • Experience working with Clinical documents (pediatrics is a plus), including ICH-GCP, FDA regulations and EMA directives
  • Proficiency with system configuration, administration, and troubleshooting of electronic document management systems and eTMF platforms such as Veeva Vault, SharePoint, TrialInteractive, etc.
  • Experience with all phases of clinical trials to support required documentation and filing for clinical operation purposes
  • Excellent in Microsoft Office, PowerPoint, other system skills
  • Ability to work independently and finish workload in a timely manner
  • Excellent written, verbal communication, and presentation skills
  • Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues