Senior Data Manager

Alira Health Group; Lido di Jesolo; In loco; EUR 40.000 - 65.000; Tempo pieno

Descrizione del lavoro

Un’azienda globale che si dedica alla salute e alle scienze della vita cerca un Senior Data Manager. La persona selezionata si occuperà di gestire le attività di data management nei progetti clinici, garantendo il rispetto degli standard di qualità e tempistiche. È richiesta una laurea in scienze della vita o esperienza nel settore; sono previsti benefits significativi come la formazione professionale e programmi di lavoro flessibili.

Servizi

Sviluppo professionale

Viaggi globali

Programmi di lavoro flessibili

Competenze

• Minimo 3 anni di esperienza nella gestione dei dati in un ambiente farmaceutico.
• Conoscenza dei processi di gestione dei dati e delle linee guida dell'industria come ICH e GCP.

Mansioni

• Gestire le attività di flusso di dati e fornire database di qualità secondo il piano del progetto.
• Condurre il team DM e monitorare i progressi rispetto al piano dello studio.

Conoscenze

Proattività

Problem-solving

Lavoro di squadra

Formazione

Laurea in scienze biologiche, farmacia o campo correlato

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.

This role 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 through to database delivery.
• Provide Data Management input into the protocol.
• Design the Case Record Form (CRF) and guide its approval process.
• Define and develop the Data Management Plan, Validation Plan, and annexes (e.g., Reconciliation Plan) with input from the study team.
• Validate the database and perform computerized checks, including SAS listings or checks.
• For EDC studies, define the User Acceptance Test (UAT) plan and execute testing to ensure quality eCRF.
• Respond promptly to issues identified by the eCRF Helpdesk.
• Prepare CRF completion guidelines and study-specific data-entry guidelines, training data-entry staff accordingly.
• Perform term coding, raise manual queries for uncoded terms, and manage discrepancy reviews and data cleaning processes.
• Create and test import programs for external data, perform data integration, and reconcile external data sources.
• Monitor study data progress, escalate issues, and define and execute QC plans and database freeze activities.
• Lead and coordinate the DM team, assign work, and monitor progress against the study plan.
• Contribute to training for new team members and ensure compliance with SOPs, GCP, and industry standards.
• Recommend process improvements, develop contacts within the study team, and maintain communication with the sponsor.
• Represent Data Management in meetings and perform other activities as required.

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 and industry guidelines like ICH, GCP.
• Familiarity with coding dictionaries such as MedDRA and WHO-DD and experience with DM systems.

Technical Skills & Soft Skills

• Proficiency in MS Office Suite.
• Professionalism, trustworthiness, prioritization skills, quality focus, willingness to learn, teamwork, learning agility, conflict management, problem-solving, technical writing, and networking skills.

Education

BSc in Biology, Life Sciences, or Pharmacy.

Contract Type

Regular

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 team of over 800 professionals from 30+ nationalities, making a tangible impact on patient care and industry standards.

Join Our Team

Apply to our open positions or send your spontaneous application to connect with our recruiters.

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