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Job DescriptionThe Lead Data Manager is responsible for all data management activities in assigned clinical trials under supervision.
- 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
- Coordinates data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables
- Provides input into monitoring of project scope, budget, timelines, and deliverables
- Is responsible for clinical data management activities including, but not limited to:
- Development of study documentation (eCRF Requirements, Edit Checks Specification, Data Management Plan, CRF Completion Guidelines, User Access Management Plan, Data Validation Plan, External Data Transfer Agreements, SAE Reconciliation Guidelines, Local Lab Normal Ranges Guidelines, Coding Guidelines where applicable)
- User acceptance testing
- User access management
- Data review
- eCRF/External data reconciliation
- Medical coding (for staff with medical/Life Science background)
- SAE reconciliation
- Query management
- Study Database Lock activities
- Archival of CRFs QC Coordination
- Project status reporting
- Data listings/Patient profiles generation
- Maintains and QCs TMF/eTMF as well as Data Management working files
- Trains Data Managers and Assistant Data Manager
- Conducts project-specific training
- College or University degree or equivalent combination of training and experience that presents the required knowledge, skills, and abilities
- Minimum of three years of industry experience in Data Management
- Two years in Data Manager role
- This role requires travel on an as needed basis for client presentations, bid defense meetings, department meetings, and the like.
All your information will be kept confidential according to EEO guidelines.
For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
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What We Do
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
