Senior Data Manager

Experteer Italy; Veneto; Ibrido; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A global data management company is looking for a Senior Data Manager to lead projects ensuring data management tasks are performed on time and within budget. The role includes collaborating with sponsors and clinical teams, managing data flow activities, and overseeing team progress. Successful candidates will have a degree in life sciences and at least 5 years of experience in data management, particularly in oncology. This position offers flexibility in remote work options across various Italian cities.

Competenze

• Degree in life sciences, pharmacy, biology, or related field, or at least 5 years of experience in data management in pharma.
• Knowledge of Data Management processes and industry guidelines (ICH, GCP).
• Experience in oncology and early-phase studies.

Mansioni

• Drive achievement of project milestones from study start-up through database delivery.
• Design the Case Record Form (CRF) and guide the approval process.
• Lead the data management team, assign work, schedule, and monitor progress.

Conoscenze

English proficiency

MS Office skills

Effective stress management

Problem-solving

Formazione

Bachelor of Science in Biology, Life Sciences, or Pharmacy

Strumenti

Medidata RAVE EDC

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 assigned studies are performed on time and within budget. They partner with Sponsors, clinical teams, and statisticians 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 the data management team, and acts as the primary contact for the Sponsor and the project’s data management responsibilities.

Role

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. They manage in-stream data flow activities, deliver a quality database in accordance with the project plan, lead the DM team, and serve as the reference point for the Sponsor and the project from a data management perspective.

Key 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 (CRF) and guide the CRF approval process.
• Define and develop the Data Management Plan, Data 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.
• Define the User Acceptance Test (UAT) Plan for EDC studies and execute testing to ensure quality eCRF.
• Respond timely to issues identified by the eCRF Helpdesk.
• Prepare CRF completion guidelines and data-entry guidelines; train data-entry staff.
• Perform term coding, raise manual queries for uncoded terms, and manage query resolution.
• Create and test import programs for external data.
• Perform data reconciliation and integration of CRF and non-CRF data.
• Monitor study data progress, manage queries, escalate issues, and ensure data quality.
• Lead the DM team, assign work, schedule, prioritize, and monitor progress.
• Contribute to training and follow SOPs, industry standards (ICH, GCP).
• 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, pharmacy, biology, or related field, or at least 5 years of experience in data management in pharma.
• Knowledge of Data Management processes and industry guidelines (ICH, GCP).
• Experience in oncology and early-phase studies.
• Proficiency in Medidata RAVE EDC.

Technical Skills & Soft Skills

• English proficiency, good MS Office skills.
• Trustworthy, quality-focused, personable, willing to learn, team player.
• Effective stress management, learning agility, conflict management, problem-solving, communication, networking skills.

Education

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

Contract Type

Regular, Full-time.

Locations

• Verona-Remote; Bologna-Remote; Verona; Milan; Bologna; Padova-Remote; Padova; Milan-Remote