Senior Clinical Data Manager / Principal Clinical Data Manager
Remote, Spain
Position Summary :
The Senior Clinical Data Manager / Principal Clinical Data Manager is responsible for managing all aspects of the clinical trial data management process from study start-up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs / WIs), regulatory directives, and study-specific plans and guidelines will be followed. This position will also oversee and / or perform database development and testing. This is a remote position; candidates can be based in the following countries: UK, Spain, Hungary, Poland, Romania, Serbia, or Slovakia.
Essential functions of the job include but are not limited to :
1. Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring back-up, continuity, responsiveness, and timely task performance. May support another Lead DM or oversee sponsor programs.
2. Oversee project data entry process including development of data entry guidelines, training, quality, and resourcing.
3. Perform quality control of data entry.
4. Provide input, assess, and manage timelines to ensure deadlines are met with quality. Assess resource needs for projects.
5. Develop CRF specifications from study protocols and coordinate review/feedback.
6. Assist in building clinical databases.
7. Conduct database build UAT and maintain documentation. Oversee database quality.
8. Specify requirements for edit check types and oversee their development.
9. Create, revise, and maintain data management documentation, ensuring completeness in the Trial Master File.
10. Train research personnel on CRF, EDC, and related items.
11. Review and query clinical trial data per the Data Management Plan.
12. Perform line listing data review and generate status reports.
13. Perform medical coding to ensure consistency.
14. Liaise with third-party vendors supporting timelines and data deliverables.
15. Assist with SAS programming and quality control if needed.
16. Identify operational problems and troubleshoot issues.
17. Assist in reviewing protocols, SAPs, and CSRs if required.
18. Participate in developing and maintaining SOPs and process documentation.
19. Attend strategy, bid, and capability meetings, and review RFPs and proposals.
20. Provide leadership for cross-functional initiatives.
21. Ensure team members are trained.
22. Communicate with sponsors, vendors, and teams regarding data issues.
23. Present software demos, training sessions, and participate in project meetings.
24. Travel as needed.
25. Perform other duties as assigned.
Qualifications : Minimum Required :
* Bachelor's degree and/or related experience.
Other Required :
* Experience as a Lead Data Manager in a CRO or pharmaceutical company.
* Proficiency in Microsoft Office Suite.
* Ability to handle various research tasks.
* Excellent organizational and communication skills.
* Professional English language skills, both written and oral.
* Experience with clinical database systems.
* Broad knowledge of drug, device, or biologic development and data management practices.
* Strong presentation, leadership, and interpersonal skills.
* Willingness to undertake occasional travel.
Preferred :
* Experience in clinical, scientific, or healthcare disciplines.
* Medical coding knowledge (MedDRA, WHODrug).
* Understanding of CDISC standards.
* Experience in oncology or orphan drugs.
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