Senior Data Manager

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

Descrizione del lavoro

A consulting and clinical development firm is seeking a Senior Data Manager to oversee data management tasks for clinical studies. The role includes developing data collection specifications, managing data flow activities, and leading the data management team. Candidates should have a degree in life sciences and experience in data management within the pharmaceutical industry.

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 pharma.
• Knowledge of Data Management processes and industry guidelines.
• Experience with DM systems.

Mansioni

• Drive achievement of project milestones and manage data flow activities.
• Define and develop the Data Management Plan and Validation Plan.
• Lead and coordinate the DM team, assign work, and prioritize tasks.

Conoscenze

Data Management processes

Knowledge of coding dictionaries

Proficiency in MS Office

Effective prioritization

Problem-solving

Formazione

Bachelor’s degrees 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 data management tasks for the assigned studies are performed on time and within budget. They partner with Sponsors, clinical, and statistics teams to develop 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 data management team, and acts as the reference point for the Sponsor and the project’s data management responsibilities.

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 (CRF) and guide the approval process.
• Define and develop the Data Management Plan, Validation Plan, and annexes.
• Validate databases and perform computerized checks, including SAS listings.
• Define and execute User Acceptance Test (UAT) plans for EDC studies.
• Respond timely to issues from the eCRF Helpdesk.
• Prepare CRF completion and data-entry guidelines, and train staff.
• Perform term coding, raise queries, and manage data cleaning.
• Create and test import programs for external data.
• Perform data reconciliation and monitor study data progress.
• Define and execute QC plans, lead database releases and freezes.
• Lead and coordinate the DM team, assign work, and prioritize tasks.
• Monitor study progress, escalate issues, and contribute to training.
• Follow SOPs, industry standards (ICH, GCP), and recommend process improvements.
• Maintain communication with the study team and represent Data Management in meetings.
• Conduct other activities as required.

Qualifications & Experience

• Degree in life sciences or related field, or at least 3 years’ experience in data management in pharma.
• Knowledge of Data Management processes and industry guidelines.
• Knowledge of coding dictionaries like MedDRA and WHO-DD.
• Experience with DM systems.

Technical Skills & Soft Skills

• Proficiency in MS Office.
• Trustworthy, professional, team player, and quality-focused.
• Effective prioritization, learning agility, conflict management, problem-solving, and networking skills.
• Languages : (Specify if needed)

Education

Bachelor’s degrees in Biology, Life Sciences, or Pharmacy preferred.

Contract Type

Regular

Alira Health is a global advisory firm providing consulting, research, and clinical development services. Our mission is to humanize healthcare and life sciences, partnering with patients through innovative technologies and expert guidance.

Why Work at Alira Health?

We offer a vibrant, creative environment with benefits including professional development, global travel, flexible work, and more. Join our passionate, talented, and entrepreneurial team.

Join Our Team

We are over 800 professionals from more than 30 nationalities, providing innovative solutions that improve standards of care and patient experiences. Apply to our open positions or send a spontaneous application.

J-18808-Ljbffr

J-18808-Ljbffr