Senior Data Manager

Alira Health Group; Napoli; In loco; EUR 40.000 - 65.000; Tempo pieno

Descrizione del lavoro

A leading global advisory firm seeks a Senior Data Manager to ensure on-time, budget-compliant DM tasks across studies. This role involves collaboration with sponsors and study teams, managing data flow, and leading the data management team. Ideal candidates should have a BSc in life sciences or equivalent experience in data management, alongside knowledge of industry guidelines and DM processes. The position offers a vibrant, creative environment with professional development and travel opportunities.

Servizi

Professional development

Global travel

Flexible work programs

Competenze

• BSc in life sciences or minimum 3 years’ experience in data management in pharma.
• Knowledge of DM processes, industry guidelines (ICH, GCP), coding dictionaries (MedDRA, WHO-DD).

Mansioni

• Drive achievement of project milestones from start-up to database delivery.
• Manage data flow activities to deliver high-quality databases.
• Lead the Data Management team and assign tasks.

Conoscenze

Trustworthiness

Teamwork

Problem Solving

Technical Writing

Formazione

BSc in life sciences

Strumenti

MS Office

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 DM tasks for assigned studies are performed on time and within budget. They partner with Sponsors, clinical, and statistics teams to develop the 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 DM team, and acts as the reference point for the Sponsor and the project’s data management lead.

Role

Ensure timely and budget-compliant DM tasks, collaborate with sponsors and study teams to develop data collection specifications, and manage data flow activities to deliver high-quality databases.

Key Responsibilities

• Drive achievement of project milestones from start-up to database delivery.
• Provide Data Management input into study protocols.
• Design CRFs and guide their approval process.
• Define and develop Data Management Plans, Validation Plans, and annexes.
• Validate databases and perform computerized checks, including SAS listings.
• Define UAT plans for EDC studies and execute testing activities.
• Respond promptly to eCRF Helpdesk issues.
• Prepare CRF completion and data-entry guidelines and train staff.
• Perform term coding, raise manual queries, and manage data discrepancies.
• Create and test data import programs from external vendors.
• Perform data reconciliation and monitor study data progress.
• Lead database release and freeze activities.
• Manage the DM team, assign work, and prioritize tasks.
• Monitor study progress, escalate issues, and contribute to training.
• Follow SOPs, industry standards, and recommend process improvements.
• Maintain communication with the study team and represent Data Management externally.
• Conduct additional activities as needed.

Desired Qualifications & Experience

• BSc in life sciences or related field, or minimum 3 years’ experience in data management in pharma.
• Knowledge of DM processes, industry guidelines (ICH, GCP), coding dictionaries (MedDRA, WHO-DD), and DM systems.

Technical Competencies & Soft Skills

• Proficiency in MS Office.
• Professionalism, trustworthiness, prioritization skills, 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 dedicated to humanizing healthcare and life sciences through innovative technologies and expert guidance, supporting clients across their solutions lifecycle.

Why Work at Alira Health?

We offer a vibrant, creative environment with benefits including professional development, global travel, flexible work programs, and more. Join our passionate, talented team of over 800 professionals from 30+ nationalities, making a meaningful impact on healthcare worldwide.

Join Our Team

Apply to our open positions or send a spontaneous application. We look forward to connecting with you!