Principal Lead Data ManagerPSI CRO • Munich, Bavaria, Germany
Principal Lead Data Manager
PSI CRO • Munich, Bavaria, Germany
Vor 5 Tagen
StellenbeschreibungActs 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.
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.
Remote Work : No
Employment Type : Full-time
Key Skills
Business Development,Classroom Experience,Dayforce,Go,Cloud Computing,AWS,Teaching,Administrative Experience,Leadership Experience,negotiation,SAS,Data Analysis Skills
Experience : years
Vacancy : 1
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Principal Manager • Munich, Bavaria, Germany
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