Clinical Document Management Specialist I

POSITION TITLE: Clinical Document Management Specialist I 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 I (CDMS I) 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 I’s are crucial for ensuring, with oversight, 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 handling such issues independently and with oversight for escalations as needed. This role reports directly to the Senior Director, Clinical Document Management while working in collaboration with various clinical study teams such as Quality Assurance, Operations, Clinical Monitoring, and Biometrics. What You’ll Do: Work within 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 through the document approval process. Liaise with project teams who ensures clinical records are filed in a timely manner. Perform quality-control (QC) review clinical and regulatory documents submitted for entry into the eTMF and liaise with project teams towards documentation issue resolution. 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. Generate/review metrics reports intended as periodic review of study files for completeness. With oversight, identify, and classify documents or other electronic content according to characteristics such as security level, function, and metadata. Supports assigned TMF corrective action plans. Work within the CDM department and with other teams to promote continual improvement within process and deliverables. Adhere to all aspects of Ora’s quality system. Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements. Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors. Responsibilities may differ from the above based on the specific needs of the business. What We Look For: Experience Needed for the Role: Bachelor’s Degree with a minimum of 1-year equivalent training and/or work experience in a medical or research field, including course work. Years of experience may be considered in lieu of education. Additional Skills and Attributes: Prior experience as a Study Coordinator, Clinical Trial Associate, or Clinical Documentation Management is strongly preferred Experience within Veeva Vau