Senior Data Manager

Alira Health Group; Ravenna; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

A global advisory firm in healthcare is seeking a Senior Data Manager to oversee data management tasks for clinical studies, ensuring timely and budget-friendly delivery. The ideal candidate will possess a degree in life sciences or equivalent experience, along with strong problem-solving and communication skills. Join a vibrant team dedicated to innovative healthcare solutions and enjoy benefits like professional development and flexible work arrangements.

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 a pharmaceutical setting.
• Knowledge of Data Management processes, industry guidelines (ICH, GCP), and coding dictionaries (MedDRA, WHO-DD).
• Experience with DM systems.

Mansioni

• Ensure DM tasks for the assigned studies are performed on time and within budget.
• Drive achievement of project milestones from start-up through database delivery.
• Design the Case Record Form and guide CRF approval process.
• Define and develop the Data Management Plan, Validation Plan, and annexes.
• Lead the DM team, assign tasks, and oversee work prioritization.

Conoscenze

English proficiency

MS Office Suite

Problem-solving

Communication

Networking

Team skills

Formazione

Bachelor of Science in Biology, Life Sciences, or Pharmacy

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 to develop the data collection specification 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 acts as the reference point for the Sponsor and the project’s data management lead.

Key Responsibilities

• Drive achievement of project milestones from start-up through database delivery.
• Provide Data Management input into the protocol.
• Design the Case Record Form and guide CRF approval process.
• Define and develop the Data Management Plan, Validation Plan, and annexes.
• Validate the database and perform computerized checks, including SAS listings.
• For EDC studies, define UAT plans and execute testing to ensure quality eCRFs.
• Respond promptly to issues identified by the eCRF Helpdesk.
• Prepare CRF completion and study-specific data-entry guidelines; train data-entry staff.
• Perform term coding, raise queries for uncoded terms, and manage discrepancy resolution.
• Create and test import programs for external data.
• Integrate data from various sources and perform reconciliation.
• Monitor study data progress, manage queries, escalate issues, and ensure quality control.
• Lead the DM team, assign tasks, and oversee work prioritization.
• Contribute to training and ensure documentation processes are followed.
• Follow SOPs, industry standards, and recommend process improvements.
• Maintain communication with the study team and represent Data Management in meetings.

Qualifications & Experience

• Degree in life sciences or related field, or at least 3 years' experience in data management in a pharmaceutical setting.
• Knowledge of Data Management processes, industry guidelines (ICH, GCP), and coding dictionaries (MedDRA, WHO-DD).
• Experience with DM systems.

Technical Skills & Soft Skills

• English proficiency, MS Office Suite.
• Professional, trustworthy, and quality-focused attitude.
• Ability to prioritize, learn, and manage conflict.
• Strong communication, problem-solving, networking, and team skills.

Education

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

Contract Type

Regular

About Alira Health

Alira Health is a global advisory firm dedicated to humanizing healthcare 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, and more. Join our diverse team of over 800 professionals from 30+ nationalities, committed to providing innovative healthcare solutions.

Join Our Team

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