ROLE SUMMARY
We are seeking an experienced Clinical Data Manager to join the team on a 12‑month fixed‑term contract, providing essential support to our clinical and study project teams. In this role, you will take full ownership of data management activities across multiple clinical studies, ensuring high‑quality data delivery from study start‑up through to database lock.
This position is ideal for someone who is detail‑oriented, proactive, and confident managing complex data workflows. Success in the role comes from working with precision, maintaining strong organisation, and collaborating effectively with cross‑functional teams to support high‑quality clinical research.
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Provide day‑to‑day data management support to the Clinical Data Management Director.
2. Lead data management deliverables across assigned clinical trials, ensuring timelines and quality standards are met.
3. Prepare, maintain, and update essential study documentation, including Data Management Plans, Data Handling Manuals, and Trial Master File content.
4. Develop Case Report Forms (CRFs) and database specifications, including eCRF design, edit checks, validation rules, and annotated CRFs.
5. Oversee EDC database setup and lead the specification and User Acceptance Testing (UAT) process.
6. Manage data reconciliation, electronic data transfers, and tracking of clinical data and images throughout the study lifecycle.
7. Perform ongoing data review, cleaning, and query management to ensure high‑quality, analysis‑ready datasets.
8. Support database lock activities, quality control processes, and preparation for statistical review.
9. Collaborate with external vendors and internal clinical teams to coordinate data‑related activities and resolve study issues.
10. Ensure all data management activities comply with GCP, 21 CFR Part 11, SOPs, and study protocols.
MINIMUM QUALIFICATIONS
11. Bachelor’s degree in science, Ophthalmology, or an Allied Healthcare field.
12. 3–5 years of clinical data management or related experience within the medical device or pharmaceutical industry.
13. Strong analytical and problem‑solving skills.
14. Effective written and verbal communication skills.
15. Working knowledge of clinical database systems (e.g., EDC, CTMS).
16. Basic programming experience (e.g., SQL, Python).
17. Understanding of GCP, GMP, clinical research processes, and regulatory requirements.
18. High proficiency in Microsoft Office and ability to learn proprietary software.
19. Strong organisational skills and attention to detail.
20. Ability to work independently and collaboratively with minimal supervision.
21. Ability to manage multiple priorities and work effectively with global/virtual team.
BENEFITS
At Optos, we offer a highly competitive compensation and benefits package.