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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 data collection specifications from all data sources.
The Senior Data Manager manages in-stream data flow activities, delivers a quality database in accordance with the project plan, leads and drives the data management team, and acts as the reference point for the Sponsor and the project’s data management lead.
Role
The Senior Data Manager ensures data management tasks are performed efficiently, partners with relevant teams to develop specifications, manages data flow activities, and leads the data management team, serving as the primary contact for data management from the sponsor’s perspective.
Key Responsibilities
1. Drive achievement of project milestones from study start-up through database delivery.
2. Provide data management input into the protocol.
3. Design Case Record Forms and guide CRF approval processes.
4. Define and develop Data Management and Validation Plans, including reconciliation and other annexes.
5. Validate databases and perform computerized checks, including SAS listings.
6. For EDC studies, define UAT plans and execute testing to ensure quality eCRFs.
7. Respond promptly to issues from the eCRF Helpdesk.
8. Prepare CRF completion and data-entry guidelines, and train staff accordingly.
9. Perform term coding, raise queries, and manage data cleaning processes.
10. Create and test import programs for electronic data from external vendors.
11. Perform data reconciliation and integration from external sources.
12. Monitor study data progress, manage queries, and escalate issues as needed.
13. Define and execute QC plans, lead database releases and freezes.
14. Lead and coordinate the data management team, assign work, and prioritize tasks.
15. Monitor study progress, escalate issues, and contribute to training.
16. Ensure adherence to SOPs, industry standards, and best practices.
17. Develop contacts within the study team and maintain communication with sponsors.
18. Represent data management in meetings and other activities.
Desired Qualifications & Experience
Degree in life sciences or related field, or at least 3 years’ experience in data management in a pharmaceutical environment. Knowledge of industry guidelines (ICH, GCP), coding dictionaries (MedDRA, WHO-DD), and DM systems.
Technical Competencies & Soft Skills
* English proficiency
* MS Office skills
* Professionalism, trustworthiness, and teamwork
* Prioritization, quality focus, and learning agility
* Stress and conflict management
* Problem-solving and communication skills
* Networking skills
Education
Bachelor’s degree in Biology, Life Sciences, or Pharmacy.
Contract Type
Regular
About Alira Health
Alira Health is a global advisory firm providing consulting, research, and clinical development services, committed to humanizing healthcare and life sciences through innovative solutions and expert guidance.
Why Work at Alira Health?
With offices worldwide, we offer a vibrant environment with benefits including professional development, global travel, flexible work arrangements, and more. We value passion, talent, entrepreneurial spirit, and teamwork.
Join Our Team
Our team includes over 800 professionals from 30+ nationalities. We invite you to apply to our open positions or send a spontaneous application.
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