Principal Lead Data Manager

Summary

Join PSI, a leading Contract Research Organization, and become a pivotal communication point for project teams, company departments, and clients regarding clinical data management. Supervise all project data management activities for assigned studies, coordinating activities such as EDC development, data collection, cleaning, and database lock. Provide input on project scope, budget, and timelines. Responsibilities include developing study documentation, user acceptance testing, data review, query management, and database archival. Maintain and QC eTMF and data management working files. Participate in audits and inspections, and train data management staff. Contribute to proposals and business development, and participate in process improvement activities. This position requires travel.

Requirements

• 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
• This position requires travel as needed for internal and external in-person meetings

Responsibilities

• 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 QCs eTMF
• Maintains and QCs 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