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Clinical Operations Document Manager

4 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:

  • Serves as the Records Manager for eTMF (electronic Trial Master File) lifecycle by doing set-up, quality review, documentation, ensures all documents are accurately uploaded and properly indexed, compliance improvement, and archiving, ensuring each are performed in accordance with Standard Operating Procedures (SOP), ICH-GCP Guidelines, EMA, FDA, and other appropriate regulations
  • Reports to the Clinical Operations Director and collaborate with the Clinical Operations Team to develop and maintain study TMF Plans and Indexes
  • Serving as primary eTMF contact for all clinical studies, ensures questions related to eTMF items are addressed in a timely manner
  • Monitors and identifies study-specific eTMF trends and communicate to Clinical Operations and/ or other functional teams as needed
  • Drives the creation of eTMF Plans, and Study-specific Master Lists and oversees execution of study TMF plans, ensuring all clinical study documentation is collected, handled, transferred, stored and/or entered into Rezolute’s eTMF in compliance with SOPs and global and local standards and requirements
  • Leads eTMF kick-off meeting for new studies, ensuring roles are assigned as per eTMF SOP, and assisting in the review and update of existing eTMF user roles bi-annually or as needed
  • Applies knowledge of the DIA TMF reference model to assist Functional Leads to revise and update study specific Master List templates and Naming Conventions
  • Liaisons with study’s PM during Inspection readiness activities to identify missing documents and identify remediation strategy to obtain missing documents
  • Supports mock inspections and act as inspection TMF SME for the assigned studies and preparing for Inspection Readiness activities including conducting TMF gap analysis activities
  • Acts as a part of core inspection team and as a backup for other clinical studies to own key responsibilities including document requests, access to the TMF for the auditors and inspectors, ensuring easy retrieval of clinical documents on request
  • Contributes 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
  • Assists 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
  • working with Clinical documents (pediatric is a plus), including ICH-GCP, FDA regulations and EMA directives is necessary
  • with electronic document management systems used in clinical research is crucial. Experience with specific eTMF platforms such as Veeva Vault, SharePoint, and others, including system configuration, administration and troubleshooting is highly desirable
  • with all phases of clinical trials to support required documentation and filing for clinical operation purposes
  • in Microsoft Office, PowerPoint, other system skills are a plus
  • 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