Inserimento Dati jobs in United States

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Job Description Summary

The Senior Data Manager ensures that data management tasks for the assigned studies are performed on time and within budget. They partner with Sponsors, clinical teams, and statisticians to develop data collection specifications from all data sources.

The Senior Data Manager manages in-stream data flow activities, delivers a quality database according to the project plan, leads the DM team, and acts as the reference point for the Sponsor and the project’s data management lead.

Responsibilities

• Drive achievement of project milestones from study start-up through to database delivery.
• Provide Data Management input into the protocol development.
• Design the Case Record Form and oversee CRF approval processes.
• Define and develop Data Management Plans, Validation Plans, and annexes such as Reconciliation Plans.
• Validate databases and perform computerized checks, including SAS listings or checks.
• For EDC studies, define User Acceptance Test plans and execute testing to ensure quality eCRFs.
• Respond promptly to issues raised by the eCRF Helpdesk.
• Prepare CRF completion and data-entry guidelines and train staff accordingly.
• Perform term coding, raise manual queries for uncoded terms, and manage query resolution.
• Create and test import programs for external data and perform data reconciliation.
• Monitor data progress reports, manage queries, and escalate issues as necessary.
• Lead database release and freeze activities, coordinate team work, and monitor study progress.
• Contribute to training and ensure compliance with SOPs, GCP, and ICH guidelines.
• Recommend process improvements and develop new standards.
• Maintain communication with the study team and represent Data Management in meetings.
• Perform other activities as required.

Qualifications & Experience

Bachelor’s degree in life sciences, pharmacy, or related field, or at least 3 years of data management experience in pharma or similar environment.

Knowledge of Data Management processes, industry guidelines (ICH, GCP), coding dictionaries (MedDRA, WHO-DD), and DM systems.

Technical Skills & Soft Skills

Education

BSc in Biology, Life Sciences, or Pharmacy.

Contract Type

Regular

About Alira Health

Alira Health is a global advisory firm in healthcare and life sciences, committed to humanizing healthcare through innovative solutions and expert guidance. We offer a vibrant work environment with opportunities for professional growth, global travel, and flexible work arrangements.

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