POSITION TITLE: 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.
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.
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.
- Manage documentation to ensure organization and accuracy.
- Perform quality-control (QC) review of clinical and regulatory documents filed in the eTMF.
- Work closely with study teams to complete timely eTMF reviews.
- Generate, review and analyze metrics reports intended as periodic review of study files for completeness.
- Train towards and actively serve as a Veeva Vault Super-user.
- Assist with the development of work processes and systems to support document management.
- May perform line management duties, mentorship and coaching to more junior members of the CDQS team.
- Travel Requirements less than 10%.
What We Look For:
- Bachelor’s degree with a minimum of 3 years’ experience with clinical documentation and record management systems (eTMF) in the clinical research field.
- Prior experience with Veeva Vault or similar systems is strongly preferred.
- Familiarity with ICH GCP, DIA TMF Reference Model and regulatory guidelines.
- Demonstrated ability to work independently and take initiative.
What We Offer:
- Competitive salaries along with a structured pension plan.
- Private medical insurance healthcare beginning day 1.
- 25 days of annual leave + Birthday PTO + bank holidays.
- Remote workspace and wellness reimbursement.
- Career development opportunities.
We are committed to equal employment opportunity and fair, equitable compensation.
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