Senior Clinical Data Manager/Principal Clinical Data Manager

buscojobs España; Pontevedra; A distancia; EUR 50.000 - 80.000; Jornada completa

Descripción de la vacante

A leading company is seeking a Senior Clinical Data Manager to manage all aspects of clinical trial data from start-up to post-database lock. This remote position requires expertise in oversight of data management processes, development of CRF specifications, and collaboration with cross-functional teams.

Formación

• Experience as a Lead Data Manager in a CRO or pharmaceutical company.
• Professional English skills (written and oral).
• Knowledge of drug, device, or biologic development.

Responsabilidades

• Serve as the primary Data Management contact for assigned projects.
• Oversee project data entry processes and ensure quality control.
• Assist in building clinical databases and develop CRF specifications.

Conocimientos

Organizational skills

Communication skills

Leadership skills

Presentation skills

Educación

Bachelor's degree

Herramientas

Microsoft Office

Descripción del empleo

Senior Clinical Data Manager / Principal Clinical Data Manager

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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 (SOPs), Work Instructions (WIs), regulatory directives, study-specific plans, and guidelines will be followed. This position will oversee and / or perform database development and testing. It is a remote position, with candidates based in the UK, Spain, Hungary, Poland, Romania, Serbia, or Slovakia.

Essential functions include :

• Serving as the primary Data Management (DM) contact (Lead DM) for assigned projects, ensuring backup, responsiveness, and timely task completion. Supporting other Lead DMs and overseeing sponsor programs as needed.
• Overseeing project data entry processes, including guideline development, training, quality control, and resourcing.
• Providing input on timelines, managing deadlines, and assessing resource needs.
• Developing CRF specifications from study protocols and coordinating review / feedback.
• Assisting in building clinical databases.
• Conducting database build UAT and maintaining quality documentation.
• Specifying requirements for edit checks and overseeing their development.
• Creating, revising, and maintaining data management documentation, ensuring completeness in the Trial Master File.
• Training research personnel on CRF, EDC, and related items.
• Reviewing and querying clinical data per the Data Management Plan.
• Performing line listing data reviews and reporting.
• Medical coding of terms for consistency.
• Liaising with third-party vendors for data and EDC support.
• Assisting with SAS programming and quality control of SAS programs.
• Identifying operational issues and troubleshooting.
• Reviewing protocols, SAPs, and CSRs as needed.
• Developing and maintaining SOPs and process documentation.
• Participating in strategy and client meetings, providing project estimates.
• Providing leadership for cross-functional initiatives and training team members.
• Communicating with sponsors, vendors, and teams regarding data issues.
• Presenting software demos and training sessions.
• Travel may be required.
• Performing other duties as assigned.

Qualifications : Minimum :

• Bachelor's degree 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 skills (written and oral).
• Experience with clinical database systems.
• Knowledge of drug, device, or biologic development and data management.
• Strong presentation, leadership, and interpersonal skills.
• Ability to travel occasionally.

Preferred :

• Experience in clinical / scientific or healthcare disciplines.
• Medical coding (MedDRA, WHODrug).
• Understanding of CDISC standards.
• Experience in oncology or orphan drugs.

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