Summary
Location
Munich
Type
full-time
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About this role
Company Description
PSI is a leading Contract Research Organization with more than 29 years in the industry, offering a perfect 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 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.
Other facts
About PSI CRO
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
What you'll do
- The Principal Lead Data Manager acts as the primary communication point for project teams and clients regarding clinical data management. They are responsible for supervising all project data management activities and coordinating data management tasks within clinical projects.
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