ppPSI 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.
/p h3Job Description /h3 ul liActs as primary communication point for project teams and company departments regarding clinical data management.
/li liActs as primary communication point for clients/vendors for all data management aspects of clinical projects and clinical data management reporting.
/li liResponsible for the supervision of all project data management activities of assigned studies.
/li liCoordinates 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.
/li liProvides input into monitoring of project scope, budget, timelines, and deliverables.
/li liResponsible 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.
/li liMaintains and QC's eTMF.
/li liMaintains and QC's Data Management working files.




/li liParticipates in preparation for and attends internal and client/third-party audits/inspections of Data Management.
/li liParticipates in follow?up on and resolution of audit findings pertaining to Data Management.
/li liTrains Lead Data Managers, Data Managers and Assistant Data Managers.
/li liConducts project?specific training of the clinical team in CRF completion and presents at the Investigator Meetings.
/li liProvides input into proposals and assists with Business Development activities.
/li liParticipates in process improvement activities at corporate/departmental level.
/li /ul h3Qualifications /h3 ul liCollege or University degree or equivalent combination of training and experience that presents the required knowledge, skills, and abilities.
/li liMinimum of five years of CRO industry experience as a Lead Data Manager or equivalent position.
/li liAt least 3 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable).
/li liProject data management experience is a plus.
/li liFull working proficiency in English.
/li liOrganizational and managerial skills.
/li /ul h3Additional Information /h3 pAdvance your career in clinical research and develop new skillsets whilst growing with the organization.
/p h3Job Details /h3 pSeniority level: Mid?Senior levelbr/Employment type: Full?timebr/Job function: Otherbr/Industries: Pharmaceutical Manufacturing /p pReferrals increase your chances of interviewing at PSI CRO by 2x.
/p /p #J-*****-Ljbffr

📌 Principal Lead Data Manager (Milano)
🏢 Psi Cro
📍 Milano