[Hiring] Clinical Document Management Specialist II @Ora

Role Description

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.
• Manage documentation to ensure organization and accuracy.
• Ensure clinical records are filed in a timely manner.
• Perform quality-control (QC) review of clinical and regulatory documents submitted for entry into the eTMF.
• Assist with the development of work processes and systems to support document management.
• Train towards and actively serve as a Veeva Vault Super-user.
• Develop and present training materials to educate trial team staff and CDMS I’s.
• Assist the clinical team in the close-out and archiving of clinical documentation and reports.
• Process and fulfill document requests from internal and external stakeholders.
• Generate/review metrics reports intended as periodic review of study files for completeness.
• Identify and classify documents or other electronic content.
• Prepare and record changes to eTMF documents.
• Assist in the development of document or content classification taxonomies.
• Assist in the preparation of support documentation and training materials for end users.
• Support assigned TMF corrective action plans.
• Clear and sustained demonstration of the Ora Clinical’s Values.
• Travel Requirements less than 10%.
• Adhere to all aspects of Ora’s quality system.

Qualifications

• Bachelor’s degree with a minimum of 3 years’ experience with clinical documentation.
• 3 years’ experience with record management systems (eTMF) in the clinical research field or equivalent combination of work experience, education, and training.

Requirements

• Prior experience with Veeva Vault, Montrium, Master Control, Documentum, Box is strongly preferred.
• Familiarity with ICH GCP, DIA TMF Reference Model and regulatory guidelines/directives.
• Familiarity with eTMF and CTMS software for document management activities.
• Prior experience working in a CRO environment.
• Familiarity with various aspects of clinical trials and regulatory submissions.
• Detailed knowledge of regulatory requirements and ICH/GCP guidelines.
• Demonstrated ability to work independently, take initiative, and mentor other team members.
• Requires strong attention to detail and document organization skills.
• Ability to communicate at multiple levels both internally and externally.
• Multi-lingual communication is a plus.

Benefits

• Comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Flexible PTO & Unlimited Sick Time.
• Competitive salaries along with a 401K plan through Fidelity with company match.
• Adoption and fertility assistance provided along with offering 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.