Senior Clinical Data Manager / Principal Clinical Data Manager

Precision for Medicine; Salamanca; A distancia; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading company is seeking a Senior Clinical Data Manager to oversee all aspects of clinical trial data management. This remote role involves managing data entry processes, ensuring quality control, and leading a team to meet project deadlines. Candidates should have a Bachelor's degree and experience in clinical data management, with strong organizational and communication skills. Join a dynamic team to contribute to innovative clinical research projects.

Formación

• Experience as a Lead Data Manager in a CRO or pharmaceutical company.
• Professional proficiency in English, both written and oral.
• Experience with clinical database management systems.

Responsabilidades

• Oversee project data entry processes and quality control.
• Develop CRF specifications and coordinate stakeholder feedback.
• Train clinical research personnel on study-specific processes.

Conocimientos

Organizational Skills

Communication Skills

Leadership Skills

Educación

Bachelor's Degree

Herramientas

Microsoft Office Suite

Descripción del empleo

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. They will follow Standard Operating Procedures / Work Instructions (SOPs / WIs), regulatory directives, study-specific plans, and guidelines. The role includes overseeing and/or performing database development and testing. This is a remote position; candidates can be based in the 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 backup, continuity, responsiveness, and timely task execution. Support may be provided to other Lead DMs or team members, including oversight of sponsor programs.
2. Oversee project data entry processes, including development of data entry guidelines, training, quality assurance, and resourcing.
3. Perform quality control of data entry as needed.
4. Provide input, assess, and manage project timelines to ensure deadlines are met with quality. Evaluate resource needs for projects.
5. Develop CRF specifications from clinical study protocols and coordinate review/feedback from stakeholders.
6. Assist in building clinical databases and conduct database build UAT, maintaining quality-controlled documentation.
7. Specify requirements for all edit check types and oversee their development.
8. Create, revise, and maintain data management documentation, ensuring completeness for the Trial Master File.
9. Train clinical research personnel on study-specific CRF, EDC, and related items.
10. Review and query clinical trial data according to the Data Management Plan.
11. Perform line listing data review based on sponsor/Lead DM guidance.
12. Generate patient and study-level reports and metrics.
13. Perform medical coding to ensure logical consistency of medical terms.
14. Coordinate with third-party vendors for data and EDC support, supporting timelines and deliverables.
15. Assist with SAS programming and quality control of SAS programs used in data management.
16. Identify operational issues and troubleshoot based on metrics, audit reports, and stakeholder input.
17. Assist in reviewing protocols, SAPs, and CSRs if required.
18. Participate in developing and maintaining SOPs and process documentation.
19. Attend strategy, bid defense, capability, and client engagement meetings.
20. Review RFPs, proposals, and provide project estimates.
21. Provide leadership for cross-functional initiatives.
22. Ensure training for all data management team members.
23. Communicate with sponsors, vendors, and project teams regarding data and database issues.
24. Present software demos, training sessions, and participate in project meetings.
25. Travel as required.
26. 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 clinical research tasks.
• Excellent organizational and communication skills.
• Professional proficiency in English, both written and oral.
• Experience with clinical database management systems.
• Broad knowledge of drug, device, or biologic development and data management best practices.
• Strong presentation, leadership, and interpersonal skills.
• Willingness to undertake occasional travel.

Preferred :

• Experience in a clinical, scientific, or healthcare discipline.
• Medical coding experience with MedDRA and WHODrug.
• Understanding of CDISC standards (CDASH, SDTM, ADaM).
• Experience in Oncology and/or Orphan Drugs.

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