Senior Clinical Data Manager/Principal Clinical Data Manager

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Senior Clinical Data Manager/Principal Clinical Data Manager, Madrid

Client:

Location:

Madrid, Spain

Job Category:

Other

EU work permit required:

Yes

Job Views:

4

Posted:

06.03.2025

Expiry Date:

20.04.2025

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 position will oversee and/or perform database development and testing. This is a remote position; candidates can be based in Serbia, Spain, UK, Hungary, Poland, Romania, or Slovakia.

Essential functions of the job include but are not limited to:

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring timely task performance and continuity.
• Oversee project data entry process, including development of guidelines, training, and quality control.
• Provide input and manage timelines, ensuring clinical data management deadlines are met with quality.
• Develop CRF specifications from the clinical study protocol and coordinate stakeholder feedback.
• Assist in building clinical databases and conduct database build UAT.
• Specify requirements for edit check types and oversee the development of specifications.
• Maintain data management documentation for the Trial Master File.
• Train clinical research personnel on study-specific CRF, EDC, and project-related items.
• Review and query clinical trial data according to the Data Management Plan.
• Run patient and study-level status and metric reporting.
• Perform medical coding of medical terms for consistency.
• Liaise with third-party vendors in a project-manager capacity.
• Identify and troubleshoot operational problems and barriers for studies.
• Participate in the development and maintenance of Standard Operating Procedures (SOPs).
• Provide leadership for cross-functional initiatives.
• Communicate with study sponsors, vendors, and project teams regarding data-related issues.
• May require some travel.
• Perform other duties as assigned.

Qualifications:
Minimum Required:

• Bachelors and/or a combination of related experience.

Other Required:

• Must have worked as a Lead Data Manager for a Clinical Research Organisation.
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Excellent organizational and communication skills.
• Professional use of the English language; both written and oral.
• Experience in utilizing various clinical database management systems.
• Broad knowledge of drug, device and/or biologic development.
• Strong leadership and interpersonal skills.
• Ability to undertake occasional travel.

Preferred:

• Experience in a clinical, scientific or healthcare discipline.
• Dictionary medical coding (MedDRA and WHODrug).
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.).
• Oncology and/or Orphan Drug therapeutic experience.