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. All contributions and new ideas are explored with an open mind, 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. They partner 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.

Role

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

They manage in-stream data flow activities, deliver a quality database, lead the DM team, and serve as the primary contact for the Sponsor from a data management perspective.

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 the CRF approval process.
• Define and develop Data Management and Validation Plans, including reconciliation procedures.
• 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 accordingly.
• Perform term coding, raise queries for uncoded terms, and manage discrepancies and data cleaning processes.
• Create and test import programs for external data.
• Perform data reconciliation and monitor study data progress reports.
• Define and execute QC plans, lead database release activities, and manage database freeze activities.
• Lead and coordinate the DM team, assign work, and prioritize tasks.
• Monitor progress against study plans and escalate issues as needed.
• Contribute to training new team members and follow SOPs and industry standards.
• Recommend process improvements and develop new standards.
• Maintain communication with the study team and represent Data Management in meetings.

Desired Qualifications & Experience

• Bachelor’s degree in life sciences, pharmacy, or related field, or at least 3 years of relevant experience.
• Knowledge of Data Management processes and industry guidelines like ICH, GCP.
• Knowledge of coding dictionaries such as MedDRA and WHO-DD.
• Experience with DM systems.

Technical Competencies & Soft Skills

• Proficiency in MS Office.
• Professionalism, trustworthiness, and effective prioritization.
• Quality focus, willingness to learn, teamwork, learning agility, conflict management, problem-solving, technical writing, and networking skills.

Education

BSc in Biology, Life Sciences, or Pharmacy.

Contract Type

Regular

About Alira Health

Alira Health is a global advisory firm providing consulting and research services in healthcare and life sciences, committed to humanizing healthcare through innovation and expertise.

Why Work at Alira Health?

We offer a vibrant, creative environment with benefits like professional development, global travel, flexible work, and more. Join our diverse team of over 800 professionals from 30+ nationalities, dedicated to innovative solutions and improved patient care.

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