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 data management 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 the data management 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 study protocols.
* Design Case Record Forms and guide their approval process.
* Define and develop Data Management Plans, Validation Plans, and related annexes.
* Validate databases and perform computerized checks, including SAS listings.
* Define UAT plans for EDC studies and execute testing activities.
* Respond promptly to issues from the eCRF Helpdesk.
* Prepare CRF completion and data-entry guidelines and train staff.
* Perform term coding, raise queries for uncoded terms, and manage query resolution.
* Create and test import programs for external data.
* Perform data reconciliation and monitor data progress reports.
* Define and execute QC plans, lead database releases and freezes.
* Lead the DM team, assign work, schedule, and prioritize tasks.
* Monitor study progress and escalate issues appropriately.
* Contribute to training 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.
* Perform other activities as required.
Qualifications & Experience
* Bachelor's degree 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.
Skills
* Professional, trustworthy, and quality-focused.
* Effective prioritization, learning agility, and team-oriented.
* Strong problem-solving, conflict management, and networking skills.
* Proficiency in technical and business writing.
* Languages: [Specify if applicable]
Education
BSc in Biology, Life Sciences, or Pharmacy.
Contract Type
Regular
About Alira Health
Alira Health is a global advisory firm dedicated to humanizing healthcare through innovative technologies and expert guidance, supporting clients across the healthcare spectrum.
Why Work at Alira Health?
We offer a vibrant, creative environment with benefits including professional development, global travel, flexible work programs, and more. Join our passionate team of over 800 professionals from diverse backgrounds.
Join Our Team
Apply to our open positions or send a spontaneous application. We look forward to hearing from you!
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