Senior Data Manager

Alira Health Group; Padova; Ibrido; EUR 45.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading global advisory firm, Alira Health Group, is seeking a Senior Data Manager to oversee data management tasks for assigned studies. This role requires extensive collaboration with diverse teams and a commitment to delivering high-quality data management solutions. Ideal candidates should possess a degree in life sciences and relevant experience, along with strong organizational, communication, and problem-solving skills. Alira offers diverse opportunities for professional growth and a flexible work environment.

Servizi

Professional development opportunities

Global travel

Flexible work programs

Diverse team environment

Competenze

• Bachelor’s degree in life sciences, pharmacy, or related field, or at least 3 years of experience in data management within a pharmaceutical environment.
• Knowledge of Data Management processes, industry guidelines, and coding dictionaries like MedDRA and WHO-DD.

Mansioni

• Drive achievement of project milestones from study start-up to database delivery.
• Provide Data Management input into the protocol.
• Design the Case Record Form and guide CRF approval processes.
• Define and develop Data Management Plans, Data Validation Plans, and related annexes.
• Validate databases and perform computerized checks.
• Define UAT plans for EDC studies and execute testing.
• Respond promptly to issues from the eCRF Helpdesk.
• Prepare CRF completion and data-entry guidelines; train staff accordingly.
• Perform term coding, raise queries for uncoded terms, and manage discrepancy resolution.
• Create and test import programs for external data.
• Perform data reconciliation and integration from external sources.
• Monitor study data progress, manage queries, and escalate issues as needed.
• Define and execute QC plans, lead database release and freeze activities.
• Lead the DM team, assign work, and prioritize tasks.
• Contribute to training for new team members.
• Follow SOPs, industry standards (ICH, GCP), and recommend process improvements.
• Maintain communication with the study team and represent Data Management in meetings.

Conoscenze

Professionalism

Effective prioritization

Focus on quality

Willingness to learn

Teamwork

Problem-solving

Strong communication

Networking

Conflict management

Formazione

Bachelor’s degree in life sciences, pharmacy, or related field

BSc in Biology

Strumenti

MS Office

Data Management systems

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 the 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.

Key Responsibilities

• Drive achievement of project milestones from study start-up to database delivery.
• Provide Data Management input into the protocol.
• Design the Case Record Form and guide CRF approval processes.
• Define and develop Data Management Plans, Data Validation Plans, and related annexes.
• Validate databases and perform computerized checks, including SAS listings/checks.
• Define UAT plans for EDC studies and execute testing to ensure quality eCRFs.
• Respond promptly to issues from the eCRF Helpdesk.
• Prepare CRF completion and data-entry guidelines; train staff accordingly.
• Perform term coding, raise queries for uncoded terms, and manage discrepancy resolution.
• Create and test import programs for external data.
• Perform data reconciliation and integration from external sources.
• Monitor study data progress, manage queries, and escalate issues as needed.
• Define and execute QC plans, lead database release and freeze activities.
• Lead the DM team, assign work, and prioritize tasks.
• Contribute to training for new team members.
• Follow SOPs, industry standards (ICH, GCP), and recommend process improvements.
• Maintain communication with the study team and represent Data Management in meetings.

Qualifications & Experience

• Bachelor’s degree in life sciences, pharmacy, or related field, or at least 3 years of experience in data management within a pharmaceutical environment.
• Knowledge of Data Management processes, industry guidelines, and coding dictionaries like MedDRA and WHO-DD.
• Experience with DM systems and technical skills in MS Office.

Skills

• Professionalism, trustworthiness, and effective prioritization.
• Focus on quality, willingness to learn, teamwork, and problem-solving skills.
• Strong communication, networking, and conflict management skills.

Education

BSc in Biology, Life Sciences, or Pharmacy.

Contract Type

Regular

About Alira Health

Alira Health is a global advisory firm committed to humanizing healthcare through innovative technologies and expert guidance. We offer a vibrant environment with professional development opportunities, global travel, flexible work programs, and more.

Why Work at Alira Health?

Join our diverse team of over 800 professionals from more than 30 nationalities, contributing to innovative solutions that improve patient care and outcomes. Apply now or send your spontaneous application.