Senior Data Manager

Alira Health; Padova; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading health technology firm is looking for a Senior Data Manager to oversee data management tasks for critical studies. This role involves developing data specifications, managing the DM team, and ensuring quality database deliverables. The successful candidate will have extensive experience in pharmaceutical data management, preferably in oncology, and will be responsible for maintaining high standards of quality while driving project milestones.

Competenze

• 5+ years experience in data management within a pharmaceutical environment.
• Knowledge of ICH and GCP guidelines.
• Experience in oncology studies, especially early phase.

Mansioni

• Drive project milestones from study start-up to database delivery.
• Define and develop Data Management and Validation Plans.
• Manage queries, discrepancies, data cleaning, and oversee data integration.

Conoscenze

Data Management

Problem Solving

Teamwork

Stress Management

Effective Communication

Networking

Formazione

Bachelor's degree in life sciences, pharmacy, or related field

BSc in Biology, Life Sciences, or Pharmacy

Strumenti

Medidata RAVE EDC

MS Office Suite

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 specification from all data sources. The Senior Data Manager manages in-stream data flow activities, delivers a quality database in accordance with the project plan, leads and drives the DM team, and acts as the reference point for the Sponsor and the appointed project data management lead.

Responsibilities

• Drive achievement of project milestones from study start-up through 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.
• Validate the database and computerized checks, including SAS listings or checks.
• For EDC studies, define the User Acceptance Test Plan (UAT) and execute test activities to ensure quality eCRF.
• Respond promptly to issues identified by the eCRF Helpdesk.
• 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, and oversee data cleaning.
• 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, and escalate issues.
• Define and execute QC plans, lead database release and freeze activities.
• Lead the DM team, assign work, prioritize tasks, and monitor progress.
• Contribute to training and ensure adherence to SOPs, industry standards like ICH, GCP.
• Recommend process improvements and develop new standards.
• Develop and maintain contacts within the study team and represent Data Management in meetings.
• Perform other activities as required.

Qualifications & Experience

• Bachelor's degree in life sciences, pharmacy, or related field, or at least 5 years' experience in data management within a pharmaceutical environment.
• Knowledge of Data Management processes, industry guidelines (ICH, GCP).
• Experience in oncology studies, especially early phase.
• Proficiency in Medidata RAVE EDC.

Technical Skills & Soft Skills

• Proficient in English and MS Office Suite.
• Trustworthy, quality-focused, personable, willing to learn, team player.
• Effective stress management, learning agility, conflict management, problem-solving skills.
• Effective verbal and technical writing skills, networking skills.

Education

BSc in Biology, Life Sciences, or Pharmacy.

Contract Type

Regular