Senior Clinical Data Manager/Principal Clinical Data Manager

Senior Clinical Data Manager/Principal Clinical Data Manager, remote, United Kingdom

Client:

Location:

Job Category:

Other

EU work permit required:

Yes

Job Reference:

58a192dca460

Job Views:

13

Posted:

26.04.2025

Expiry Date:

10.06.2025

Job Description:

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. This includes following SOPs/WIs, regulatory directives, study plans, and guidelines. The role involves overseeing and/or performing database development and testing. Candidates can be based remotely in Serbia, Spain, UK, Hungary, Poland, Romania, or Slovakia.

Essential functions include but are not limited to:

1. Primary Data Management (DM) contact (Lead DM) for assigned projects, ensuring backup, responsiveness, and timely task completion. Support may be provided to other Lead DMs or sponsor programs.
2. Oversee project data entry, develop data entry guidelines, and ensure quality and resourcing.
3. Perform quality control of data entry if required.
4. Manage timelines, ensure deadlines are met, and assess resource needs.
5. Develop CRF specifications from study protocols and coordinate stakeholder reviews.
6. Assist in building clinical databases and conduct UAT for database build, maintaining documentation.
7. Specify requirements for edit checks and oversee their development.
8. Create and maintain data management documentation, ensuring completeness for the Trial Master File.
9. Train clinical research personnel on CRF, EDC, and related items.
10. Review and query clinical trial data, perform line listing reviews, and generate reports.
11. Perform medical coding of terms for consistency.
12. Liaise with third-party vendors and support SAS programming and quality control if needed.
13. Identify operational issues and provide feedback on protocols, SAPs, and CSRs if required.
14. Participate in developing SOPs and process documentation.
15. Attend strategy and client meetings, review RFPs, and provide project estimates.
16. Lead cross-functional initiatives and ensure team training.
17. Communicate with sponsors, vendors, and project teams regarding data issues.
18. Present software demos, training sessions, and participate in project meetings.
19. Travel as needed and perform other duties as assigned.

Qualifications:

Minimum Required:

• Bachelor’s degree or equivalent experience.

Other Required:

• Experience as a Lead Data Manager in a CRO.
• Proficiency in Microsoft Office.
• Ability to handle diverse clinical research tasks.
• Excellent organizational and communication skills.
• Professional-level English language skills.
• Experience with clinical database management systems.
• Broad knowledge of drug, device, or biologic development and data management practices.
• Strong communication, 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.

Note: If not a passport holder of the country for the vacancy, a work permit may be required. For more info, visit our Blog. Do not include bank or payment details in your application. Apply via the 'Apply now' button.