Senior Data Manager

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive, and elevate others.

Job Description Summary

The Senior Data Manager ensures DM tasks for the assigned studies are performed on time and within budget, partnering with Sponsors, clinical, and statistics teams to develop the 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 and drives the DM team, and acts as the reference point for the Sponsor and the project’s data management lead.

Key Responsibilities

• Drive achievement of project milestones from study start-up to database delivery.
• Provide Data Management input into the protocol.
• Design the Case Record Form and guide its approval process.
• Define and develop Data Management and Validation Plans, including Reconciliation Plans, with input from the study team.
• Validate the database and perform computerized checks, including SAS listings or checks.
• For EDC studies, define UAT plans and execute testing to ensure quality eCRFs.
• Respond promptly to issues identified by the eCRF Helpdesk.
• Prepare CRF completion and data-entry guidelines and train staff.
• Perform term coding, raise queries for uncoded terms, and manage queries and data cleaning processes.
• Create and test import programs for external data.
• Perform data reconciliation and integration from external sources.
• Monitor study data progress, manage queries, escalate issues, and ensure QC activities.
• Lead the DM team, assign work, and prioritize tasks.
• Contribute to training and ensure compliance with SOPs and industry standards.
• Recommend process improvements and develop new standards.
• Maintain communication with the study team and represent Data Management in meetings.

Qualifications & Experience

• BSc in Life Sciences, Pharmacy, or related field, or at least 3 years’ experience in data management in a pharmaceutical environment.
• Knowledge of Data Management processes, industry guidelines (ICH, GCP), and coding dictionaries (MedDRA, WHO-DD).
• Experience with DM systems and MS Office Suite.

Skills

• Professionalism, trustworthiness, and quality focus.
• Effective prioritization, teamwork, learning agility, conflict management, problem-solving, and networking skills.

Education

BSc in Biology, Life Sciences, or Pharmacy.

Contract Type

Regular

About Alira Health

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

Join Our Team

We are a diverse team of over 800 professionals from more than 30 nationalities. Apply now or send us your spontaneous application. We look forward to hearing from you!