Clinical Document Management Specialist II

POSITION TITLE: Clinical Document Management Specialist II DEPARTMENT: Clinical Document Management Ora Values the Daily Practice of … Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor At Ora, we are building the future of ophthalmic clinical research. As the world’s leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America. The Role: Ora’s Clinical Documentation Management Specialists II (CDMS II) is responsible for the management, quality and oversight of the electronic Trial Master File (eTMF) associated with all phases of assigned clinical trials (i.e., set-up through final transfer / archival). CDMS II’s are crucial for ensuring Ora’s clinical teams operate in compliance with SOPs and processes, study sponsor expectations and all applicable regulations. This role will focus on the quality of documents being uploaded to the eTMF and monitoring compliance to the TMF relative to inspection readiness and handle such issues independently and with oversight for escalations as needed. Additionally, our CDMS II’s have the responsibility of preparing documentation required for regulatory agency inspections and internal audits. This role reports directly to the Manager while working in collaboration with various clinical study teams such as Quality Assurance, Chemical Manufacturing Control, and Medical Devices. Ora’s CDMS II’s will train to become Veeva Vault Super Users and be responsible for providing support and training to more junior team members, identify process improvements, handle escalations for documentation resolutions. What You’ll Do: Implement and administer Ora document management systems (Veeva Vault) and related procedures that allow Ora staff to capture, store, retrieve, share, and destroy electronic records and documents in a manner consistent and in accordance with SOPs, ICH GCP guidelines, FDA, and EU Directive (and other global regulatory agencies as needed). Manage documentation to ensure organization and accuracy. Ensures clinical records are filed in a timely manner. Perform quality-control (QC) review of clinical and regulatory documents submitted for entry into the eTMF and liaise with project teams towards documentation issue resolution. Assist with the development of work processes and systems to support document management, including contributing to SOPs and internal department guidance. Supports initiatives to enhance efficiencies in document management practices. Propose recommendations for improving content management system capabilities. Train towards and actively serve as a Veeva Vault Super-user who: Provides support and training to team members on processes and eTMF/CTMS software. Supports staff towards resolution of ad hoc system issues. Drives the resolution of identified documentation issues. Develop and present training materials to educate trial team staff and CDMS I’s on the usage of Veeva, Good Documentation Practices, Ora processes and regulatory guidelines. Assist the clinical team in the close-out and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Process and fulfill document requests from internal and external stakeholders for studies which have been archived in the eTMF. Generate/review metrics reports intended as periodic review of study files for completeness. Identify and classify documents or other electronic content according to characteris