Senior Data Manager

Alira Health Group; Milano; In loco; EUR 35.000 - 60.000; Tempo pieno

Descrizione del lavoro

Alira Health Group seeks a Senior Data Manager to oversee data management tasks for clinical studies, ensuring timely and quality deliverables. The role involves collaboration with various teams to develop data specifications and manage data flow activities while leading the data management team. A commitment to quality and professional development in a dynamic environment awaits you.

Servizi

Professional development

Global travel

Flexible work programs

Competenze

• Degree in life sciences or related field.
• At least 3 years’ experience in data management.
• Knowledge of Data Management processes and industry guidelines (ICH, GCP).

Mansioni

• Drive project milestones from study start-up to database delivery.
• Design Case Record Forms and develop Data Management Plans.
• Lead the data management team and validate databases.

Conoscenze

Data Management

Team Leadership

Problem Solving

Communication

Quality Focus

Formazione

Bachelor’s degree in Biology, Life Sciences, or Pharmacy

Strumenti

MS Office Suite

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 data management tasks for 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 according to 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 is responsible for ensuring data management tasks are completed timely and within budget, collaborating with various teams to develop data collection specifications, managing data flow activities, and leading the data management team.

Key Responsibilities

1. Drive achievement of project milestones from study start-up to database delivery.
2. Provide data management input into study protocols.
3. Design Case Record Forms and guide CRF approval processes.
4. Develop Data Management Plans, Validation Plans, and related annexes with input from the study team.
5. Validate databases and perform computerized checks, including SAS listings.
6. Define and execute User Acceptance Test Plans for EDC studies to ensure quality eCRFs.
7. Respond promptly to issues identified by the eCRF Helpdesk.
8. Prepare CRF completion and data-entry guidelines, and train staff accordingly.
9. Perform term coding, raise queries for uncoded terms, and manage discrepancies and data cleaning processes.
10. Create and test import programs for external data and perform data reconciliation.
11. Monitor data progress reports, manage queries, escalate issues, and lead database release activities.
12. Lead and coordinate the data management team, assigning work and prioritizing tasks.
13. Contribute to study project planning and communicate effectively with sponsors.
14. Represent Data Management in meetings and follow SOPs and industry standards.
15. Suggest process improvements and develop new standards.
16. Maintain contacts within the study team and ensure effective communication with sponsors.
17. 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 a pharmaceutical environment.
• Knowledge of Data Management processes and industry guidelines (ICH, GCP).
• Knowledge of coding dictionaries like MedDRA and WHO-DD.
• Experience with DM systems.

Technical Skills & Soft Skills

• Proficiency in MS Office Suite.
• Professionalism, trustworthiness, and ability to prioritize effectively.
• Focus on quality, willingness to learn, teamwork, learning agility, conflict management, problem-solving, technical and business writing, 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 technologies and expert guidance.

Why Work at Alira Health?

We offer a vibrant environment with benefits including professional development, global travel, flexible work programs, and more. Join our passionate, talented, and entrepreneurial team.

Join Our Team

We are a diverse team of over 800 professionals from more than 30 nationalities. Apply to our open positions or send us your spontaneous application. J-18808-Ljbffr