Clinical Document Quality Specialist II

DEPARTMENT: Ora Europe

LOCATION: Remote – UK, Italy or Spain

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 forty years, our expert teams have helped earn more than fifty new product approvals. Today, our team continues to expand across the globe, with over 350 employees across the US, Europe, Australia, and Asia.

The Role:

Ora’s Clinical Documentation Quality Specialist II (CDQS 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). CDQS 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 oversight of 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 CDQS II’s have the responsibility of preparing documentation required for regulatory agency inspections and internal audits. This role reports directly to the Clinical Document Quality Manager while working in collaboration with various clinical study teams such as Quality Assurance, Chemical Manufacturing Control, and Medical Devices. Ora’s CDQS II’s will train to become Veeva Vault Super Users and be responsible for providing support and training to department team members including Clinical Trial Associates (CTAs) and Clinical Research Associates (CRAs) as well as more junior members of the CDQS team, 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 documents are filed in a timely manner, following up with relevant team members as necessary.
• Perform quality-control (QC) review of clinical and regulatory documents filed in the eTMF and liaise with project teams towards documentation issue resolution.
• Work closely with study teams to complete timely eTMF reviews.
• Provision of outstanding essential document requirements to CRAs in support of their monitoring visits and ED collection periodically throughout the course of a study.
• 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 and analyze metrics reports intended as periodic review of study files for completeness.
• Collaborate with CRAs and other relevant functions to build and maintain local country Essential Document (ED) intelligence.
• 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 deliver training materials to educate trial team staff and CDQS I’s, CRAs, CTAs and other relevant team members on the usage of Veeva, Good Documentation Practices, Ora processes and regulatory guidelines.
• Assist with the processing and fulfilling of document requests from internal and external stakeholders for studies which have been archived in the eTMF.
• Assist with CDQS study allocation and interaction with the study team.
• Working closely with study team assist in developing study-specific eTMF review schedule
• Identify and classify documents or other electronic content according to characteristics such as security level, function, and metadata.
• With oversight, 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 eTMF and ED corrective action plans.
• May perform line management duties, mentorship and coaching to more junior members of the CDQS team.
• Responsibilities may differ slightly from the above based on specific needs of the business.
• Travel Requirements less than 10%
• Clear and sustained demonstration of the Ora Clinical’s Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.

What We Look For:

• Experience Needed for the Role:
• 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. Years of experience may be considered in lieu of education
• Additional Skills and Attributes:
• Prior experience 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, 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 mentoring 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.
• Multi-lingual communication is a plus
• Competencies and Personal Traits:
• Attention to Detail: Ability to analyze data to drive successful solutions to complex problems.
• Emotionally Intelligent Leadership: Ability to lead with a positive mindset and empathy.
• Intellectual Curiosity: Willingness and desire to learn new things and dig deeper than the surface.
• Innovative Mindset: Forward thinking, creative and open to testing, making mistakes and trying again.
• Organization and Goal Setting: Ability to set goals, develop structure and maintain a focused approach to critical path work.
• Resolve Conflicts: Practice radical candor in your communication and participate in active listening to help the other person feel heard and understood.
• Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world.

What We Offer:

• Financial: Competitive salaries along with a structured pension plan.
• Well Being: Offering private medical insurance healthcare beginning day 1 provided by Vitality and Simply Health.
• Company Paid Life & Disability Insurance: Offering peace of mind through Canada Life to help you and your family feel secure.
• PTO: 25 days of annual leave + Birthday PTO + bank holidays.
• Remote & Wellness Reimbursement: We’ll reimburse you to support your remote workspace and wellness purchases.
• Career Development Opportunities: Continued opportunities to grow and develop your career journey.
• Global Team: Opportunities to work with colleagues across the globe.
• Impact: A chance to research new ophthalmic therapies that will impact patients across the globe.

Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.

Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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