Clinical Document Quality Specialist II

POSITION TITLE: Clinical Document Quality Specialist II/ eTMF Specialist

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.
• Ensure clinical documents are filed in a timely manner, following up with relevant team members as necessary.
• Work closely with study teams to complete timely eTMF reviews
• 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 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 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 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.
• Ensure CDQS study allocation and interaction with the study teams
• Work closely with study team to develop study-specific eTMF review schedule
• 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 team.
• 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.
• 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 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:
  • What We Do:
    • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
  • How We Do It:
    • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
    • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
  • Why We Do It:
    • 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. At Ora, we are creating vision beyond what we see.

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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