Clinical Document Management Specialist II

Ora

28d • Remote

About The Position

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.

Requirements

• Bachelor’s degree with a minimum of 3 years’ experience with clinical documentation and 3 years’ experience with record management systems (eTMF) in the clinical research field or equivalent combination of work experience, education, and training.
• Familiarity with ICH GCP, DIA TMF Reference Model and regulatory guidelines/directives.
• Familiarity with eTMF and CTMS software for document management activities.
• Familiarity with various aspects of clinical trials and regulatory submissions, as well as strong knowledge of document management best practices.
• Detailed knowledge of regulatory requirements and ICH/GCP guidelines to support clinical records management.
• Demonstrated ability to work independently, take initiative, complete tasks to deadlines and mentor other team members
• Ability to learn and apply SOPs and process governance regulations pertaining to clinical study documentation.
• Requires strong attention to detail, document organization skills, establishing priorities, scheduling and meeting deadlines in order to meet business demands.
• Ability to communicate at multiple levels both internally and externally and to concisely explain/rationalize responses to issues while able to guide study teams, sponsors and vendors towards the proper and most efficient manner of documentation and documentation maintenance.

Nice To Haves

• Prior experience Veeva Vault, Montrium, Master Control, Documentum, Box is strongly preferred.
• Prior experience working in a CRO environment
• Multi-lingual communication is a plus

Responsibilities

• 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, and 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 characteristics such as security level, function, and metadata.
• Prepare and record changes to eTMF documents and confirm changes with legal and compliance management staff.
• Assist in the development of document or content classification taxonomies to facilitate information capture, search, and retrieval.
• Assist in the preparation of support documentation and training materials for end users of document management systems.
• Supports assigned TMF corrective action plans.
• Travel Requirements less than 10%
• 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.

Benefits

• Comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Flexible PTO & Unlimited Sick Time
• 14 company paid holidays
• Competitive salaries
• 401K plan through Fidelity with company match.
• Adoption and fertility assistance provided
• 16 weeks paid Parental Leave.
• Company Paid Life & Disability Insurance
• Remote & Wellness Reimbursement
• Employee Assistance Program
• Continued opportunities to grow and develop your career journey.
• Opportunities to work with colleagues across the globe.
• A chance to research new ophthalmic therapies that will impact patients across the globe.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level