Senior Data Manager

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

Descrizione del lavoro

Un'azienda internazionale di consulenza cerca un Senior Data Manager per garantire che le attività di gestione dei dati siano eseguite nei tempi e nei budget previsti. La posizione comporta la gestione del flusso dei dati, la convalida del database e la guida di un team. I candidati ideali possiedono una laurea in scienze della vita e almeno 3 anni di esperienza, oltre a una buona conoscenza delle linee guida dell'industria.

Servizi

Sviluppo professionale

Viaggi globali

Programmi di lavoro flessibili

Competenze

• Almeno 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 (ICH, GCP).
• Esperienza con uno o più sistemi di DM.

Mansioni

• Guidare il raggiungimento dei traguardi del progetto dalla start-up dello studio alla consegna del database.
• Validare il database e svolgere controlli computerizzati, inclusi elenchi SAS.
• Gestire le query: rivedere le discrepanze, risolvere e chiudere le query.

Conoscenze

Proficienza in inglese

Competenze in MS Office Suite

Problem-solving

Formazione

Laurea in Biologia, Scienze della vita o Farmacia

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. Where all contributions and new ideas are explored with an open mind and work is 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 responsible from a data management perspective.

Role

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.

They manage in-stream data flow activities, deliver a quality database according to the project plan, lead the DM team, and serve as the main contact for the Sponsor and the project team from a data management perspective.

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 the Data Management Plan, Data Validation Plan, and their 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 Plan (UAT) and execute testing to ensure quality eCRF.
• Respond promptly to issues identified by the eCRF Helpdesk in EDC studies.
• Prepare CRF completion guidelines and study-specific data-entry guidelines; train data-entry staff.
• Perform term coding, raise manual queries for uncoded terms.
• Manage queries: review discrepancies, resolve, and close queries; oversee data cleaning including manual checks and listings.
• Create and test import programs for external data.
• Perform data integration and reconciliation of external data sources.
• Monitor study data progress reports, manage query resolution, escalate issues as needed.
• Define and execute QC plans, lead database release and freeze activities.
• Lead the DM team, assign work, prioritize tasks.
• Monitor study progress against the project plan and escalate issues.
• Contribute to training new team members.
• Follow SOPs, industry standards (ICH, GCP), and document management procedures.
• Recommend process improvements and develop new standards.
• Maintain communication with the study team and sponsor, represent Data Management in meetings.
• Perform other activities as required.

Desired Qualifications & Experience

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

Technical Competencies & Soft Skills

• English proficiency.
• MS Office Suite skills.
• Professionalism, trustworthiness, effective prioritization, quality focus, personable attitude, willingness to learn, team player, stress management, learning agility, conflict management, problem-solving, verbal and technical writing skills, networking skills.

Education

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

Contract Type

Regular

About Alira Health

Alira Health is a global advisory firm providing consulting, research, and clinical development services. Our mission is to humanize healthcare and life sciences through innovative technologies and expert guidance. We support Pharma, Biotech, and MedTech clients across their solutions lifecycle.

Why Work at Alira Health?

With offices worldwide, we offer a vibrant environment with benefits including professional development, global travel, flexible work programs, and more. Join our passionate and talented team!

Join Our Team

We are an international team of over 800 professionals from more than 30 nationalities. This diversity enhances our ability to provide innovative solutions that improve standards of care and patient experiences.

Apply via our open positions or send a spontaneous application to our recruiters.

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