Principal Lead Data Manager

PSI CRO; Milano; On-site; EUR 45,000 - 65,000; Full time

Job summary

A leading Contract Research Organization is looking for a mid-senior level Lead Data Manager in Milan. The role involves overseeing clinical data management activities, ensuring quality service delivery, and training project team members. Candidates should possess at least five years of experience in the CRO industry with a strong background in data management systems like Medidata Rave or Oracle Inform, as well as excellent communication and organizational skills. This full-time position offers growth opportunities within the industry.

Qualifications

• Minimum of five years of CRO industry experience as a Lead Data Manager or equivalent position.
• At least 3 years of experience using CDM/EDC systems.
• Full working proficiency in English.

Responsibilities

• Acts as primary communication point for project teams and company departments regarding clinical data management.
• Coordinates data management activities within clinical projects.
• Trains Lead Data Managers, Data Managers and Assistant Data Managers.

Skills

Data management

Project management

Organizational skills

Communication proficiency

Education

College or University degree

Tools

Medidata Rave

Oracle Inform

Job description

PSI is a leading Contract Research Organization with more than 29 years in the industry, offering a balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

• Acts as primary communication point for project teams and company departments regarding clinical data management.
• Acts as primary communication point for clients/vendors for all data management aspects of clinical projects and clinical data management reporting.
• Responsible for the supervision of all project data management activities of assigned studies.
• Coordinates data management activities within clinical projects including but not limited to EDC development, data collection, cleaning, reconciliation, database lock activities, development of final integrated database and generation of final data management deliverables.
• Provides input into monitoring of project scope, budget, timelines, and deliverables.
• Responsible for clinical data management activities including, but not limited to: development of study documentation, user acceptance testing, user access management, data review, eCRF/External data reconciliation, SAE reconciliation, query management, study database lock activities, archival of CRFs, QC coordination, project status reporting, data listings/Patient profiles generation and delivery.
• Maintains and QC’s eTMF.
• Maintains and QC’s Data Management working files.
• Participates in preparation for and attends internal and client/third-party audits/inspections of Data Management.
• Participates in follow‑up on and resolution of audit findings pertaining to Data Management.
• Trains Lead Data Managers, Data Managers and Assistant Data Managers.
• Conducts project‑specific training of the clinical team in CRF completion and presents at the Investigator Meetings.
• Provides input into proposals and assists with Business Development activities.
• Participates in process improvement activities at corporate/departmental level.

Qualifications

• College or University degree or equivalent combination of training and experience that presents the required knowledge, skills, and abilities.
• Minimum of five years of CRO industry experience as a Lead Data Manager or equivalent position.
• At least 3 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable).
• Project data management experience is a plus.
• Full working proficiency in English.
• Organizational and managerial skills.

Additional Information

Advance your career in clinical research and develop new skillsets whilst growing with the organization.

Job Details

Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Other
Industries: Pharmaceutical Manufacturing

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