Senior Data Manager

Alira Health Group; Reggio Emilia; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A global advisory firm is seeking a Senior Data Manager to manage data flow activities and lead the DM team. This role involves ensuring timely completion of data management tasks, overseeing quality assurance of databases, and maintaining communication with project stakeholders. Candidates should have a degree in life sciences or relevant experience in pharmaceutical data management.

Servizi

Professional development

Global travel

Flexible work

Competenze

• Degree in life sciences or related field, or at least 3 years’ experience in data management in pharma.
• Knowledge of data management processes and industry guidelines (ICH, GCP).
• Experience with coding dictionaries like MedDRA and WHO-DD.
• Proficiency in DM systems.

Mansioni

• Drive achievement of project milestones from study start-up to database delivery.
• Provide input into the study protocol.
• Design the Case Record Form (CRF) and oversee its approval process.
• Develop Data Management Plans, Validation Plans, and annexes with input from the study team.
• Validate databases and perform computerized checks, including SAS listings.
• Define and execute UAT plans for EDC studies to ensure quality eCRF.
• Respond promptly to issues identified by the eCRF Helpdesk.
• Prepare CRF completion and data-entry guidelines and train staff.
• Perform term coding and raise manual queries as needed.
• Manage queries, review discrepancies, and oversee data cleaning processes.
• Create and test import programs for external data.
• Integrate and reconcile external data sources.
• Monitor data progress reports and escalate issues as needed.
• Define and execute QC plans, lead database releases and freezes.
• Lead and coordinate the DM team, assign tasks, and prioritize work.
• Track progress against the study plan and escalate issues.
• Contribute to training and adhere to SOPs, GCP, and industry standards.
• Recommend process improvements and develop standards.
• Maintain communication with the study team and sponsor, represent DM in meetings.
• Perform other activities as required.

Descrizione del lavoro

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 that data management (DM) tasks for assigned studies are performed on time and within budget. They collaborate 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 according to the project plan, leads the DM team, and serves as the reference point for the Sponsor and the project’s data management lead.

Role

Responsibilities include managing data flow activities, delivering quality databases, leading the DM team, and acting as the point of contact for data management from the sponsor and project perspective.

Key Responsibilities

1. Drive achievement of project milestones from study start-up to database delivery.
2. Provide input into the study protocol.
3. Design the Case Record Form (CRF) and oversee its approval process.
4. Develop Data Management Plans, Validation Plans, and annexes with input from the study team.
5. Validate databases and perform computerized checks, including SAS listings.
6. Define and execute UAT plans for EDC studies to ensure quality eCRF.
7. Respond promptly to issues identified by the eCRF Helpdesk.
8. Prepare CRF completion and data-entry guidelines and train staff.
9. Perform term coding and raise manual queries as needed.
10. Manage queries, review discrepancies, and oversee data cleaning processes.
11. Create and test import programs for external data.
12. Integrate and reconcile external data sources.
13. Monitor data progress reports and escalate issues as needed.
14. Define and execute QC plans, lead database releases and freezes.
15. Lead and coordinate the DM team, assign tasks, and prioritize work.
16. Track progress against the study plan and escalate issues.
17. Contribute to training and adhere to SOPs, GCP, and industry standards.
18. Recommend process improvements and develop standards.
19. Maintain communication with the study team and sponsor, represent DM in meetings.
20. Perform other activities as required.

Desired Qualifications & Experience

• Degree in life sciences or related field, or at least 3 years’ experience in data management in pharma.
• Knowledge of data management processes and industry guidelines (ICH, GCP).
• Experience with coding dictionaries like MedDRA and WHO-DD.
• Proficiency in DM systems.

Technical Competencies & Soft Skills

• Fluent in English.
• Proficient in MS Office.
• Trustworthy, professional, quality-focused.
• Effective prioritization, teamwork, stress management, problem-solving, communication skills.
• Willingness to learn, network, and manage conflicts.

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 technologies and expert guidance.

Why Work at Alira Health?

We offer a vibrant, creative environment with benefits including professional development, global travel, flexible work, and more. Join our passionate, talented team dedicated to advancing healthcare.

Join Our Team

We are a diverse team of over 800 professionals from more than 30 nationalities, providing innovative solutions to improve patient care. Apply to our open positions or send a spontaneous application.

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