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Job Description Summary
The Senior Data Manager ensures data management tasks for 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 and drives the data management team, and acts as the primary contact for the Sponsor and the project’s data management lead.
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 the Case Record Form and guide its approval process.
4. Define and develop the Data Management Plan, Data Validation Plan, and annexes (e.g., Reconciliation Plan) with input from the study team.
5. Validate the database and perform computerized checks, including SAS listings or checks.
6. For EDC studies, define the User Acceptance Test (UAT) plan and execute testing to ensure quality eCRF.
7. Respond promptly to issues identified by the eCRF Helpdesk.
8. Prepare CRF completion guidelines and study-specific data-entry guidelines; train data-entry staff.
9. Perform term coding, raise manual queries for uncoded terms as needed.
10. Manage queries: review discrepancies, resolve, and close queries; oversee data cleaning.
11. Create and test import programs for external data.
12. Perform data integration and reconciliation of external data sources.
13. Monitor study data progress, manage queries, escalate issues.
14. Define and execute QC plans, lead database release and freeze activities.
15. Lead the DM team, assign work, schedule, prioritize.
16. Monitor progress against the study plan and escalate issues.
17. Contribute to training for new team members.
18. Follow SOPs, industry standards (ICH, GCP), and recommend process improvements.
19. Maintain communication with the sponsor and represent Data Management in meetings.
20. Perform other activities as required.
Qualifications & Experience
* BSc in life sciences, pharmacy, or related field, or at least 3 years’ experience in data management in pharma.
* Knowledge of Data Management processes and industry guidelines (ICH, GCP).
* Knowledge of coding dictionaries (MedDRA, WHO-DD) and DM systems.
Skills
* Proficiency in MS Office.
* Professionalism, trustworthiness, ability to prioritize, quality focus, willingness to learn.
* Teamwork, learning agility, conflict management, problem-solving, technical writing, 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 to humanize healthcare and life sciences, partnering with patients through innovative technologies 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 programs, and more.
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