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 specification 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 DM team, and acts as the reference point for the Sponsor and the appointed project data management lead.

Job Description

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 specification from all data sources.

The Senior Data Manager manages in-stream data flow activities, delivers a quality database, leads the DM team, and acts as the reference point for the Sponsor and the project data management lead.

Key Responsibilities

1. Drive achievement of project milestones from study start-up to database delivery.
2. Provide Data Management input into the protocol.
3. Design the Case Record Form and guide the CRF approval process.
4. Define and develop the Data Management Plan, Validation Plan, and annexes.
5. Validate the database and computerized checks, including SAS listings or checks.
6. For EDC studies, define the UAT plan and execute test activities to ensure quality eCRF.
7. Respond timely to issues identified by the eCRF Helpdesk.
8. Prepare CRF completion and data-entry guidelines and train staff.
9. Perform term coding, raise queries, review discrepancies, and manage data cleaning.
10. Create and test import programs for external data.
11. Perform data integration and reconciliation of external data sources.
12. Monitor study data progress reports, manage queries, escalate issues.
13. Define and execute QC plans, lead database release and freeze activities.
14. Lead and coordinate the DM team, assign work, schedule, and prioritize.
15. Monitor progress against study plans and escalate issues.
16. Contribute to training and follow SOPs, industry standards like ICH, GCP.
17. Recommend process improvements and develop new standards.
18. Develop and maintain contacts within the study team.
19. Maintain communication with sponsors, represent Data Management in meetings.
20. Conduct other activities as required.

Desired Qualifications & Experience

• Degree in life sciences, pharmacy, or related field, or at least 5 years' experience in data management in pharma.
• Knowledge of Data Management processes, industry guidelines like ICH, GCP.
• Experience in oncology studies, especially early phase.
• Proficiency with Medidata RAVE EDC.

Technical Competencies & Soft Skills

• English proficiency, good MS Office skills.
• Trustworthy, quality-focused, personable, eager to learn, team player.
• Stress management, learning agility, conflict management, problem-solving.
• Effective communication, technical writing, networking skills.

Languages

English

Education

Bachelor of Science in Biology, Life Sciences, or Pharmacy.

Contract Type

Regular