Alira Health SRL
Senior Data Manager
Job Location
Verona, Italy
Job Description
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 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 and drives the DM team, and acts as the reference point for the Sponsor and the project’s data management lead. Role The Senior Data Manager ensures DM tasks are completed on schedule and budget, collaborates with sponsors and study teams to develop data collection specifications, manages data flow activities, and leads the DM team, serving as the primary contact for data management aspects of the project. 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 the CRF approval process. Define and develop Data Management and Validation Plans, including reconciliation plans. Validate databases and perform computerized checks, including SAS listings. For EDC studies, define and execute UAT plans to ensure quality eCRFs. Respond promptly to issues identified by the eCRF Helpdesk. Prepare CRF completion and data-entry guidelines and train staff. Perform term coding, raise queries for uncoded terms, and manage query resolution and data cleaning. Create and test import programs for external data. Integrate CRF and non-CRF data, perform reconciliation of external data, and monitor data progress reports. Define and execute QC plans, lead database freeze activities, and manage the DM team’s work prioritization. Contribute to training, follow SOPs, recommend process improvements, and maintain communication with the sponsor. Represent Data Management in meetings and perform other activities as needed. 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, industry guidelines (ICH, GCP), coding dictionaries (MedDRA, WHO-DD), and DM systems. Technical Competencies & Soft Skills Proficiency in MS Office. Professional, trustworthy, and quality-focused. Effective prioritization, willingness to learn, team-oriented, and adaptable. Strong problem-solving, communication, and networking skills. Education BSc in Biology, Life Sciences, Pharmacy, or related fields. Contract Type Regular About Alira Health Alira Health is a global advisory firm committed to humanizing healthcare and life sciences through innovative technologies and expert guidance, supporting clients across their entire solutions lifecycle. Why Work at Alira Health? We offer a vibrant, creative environment with benefits including professional development, global travel, flexible work options, and more. Join our diverse team of over 800 professionals from 30 nationalities, making a meaningful impact on healthcare standards and patient experiences. Join Our Team Apply to our open positions or send a spontaneous application. We look forward to hearing from you! J-18808-Ljbffr
Location: Verona, Veneto, IT
Posted Date: 8/22/2025
Location: Verona, Veneto, IT
Posted Date: 8/22/2025
Contact Information
Contact | Human Resources Alira Health SRL |
---|