Lead Data Manager
Lead Data Manager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The 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 projectspecific training
Qualifications :
- 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.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
Company Industry
Key Skills
- SQL
- Data Collection
- GCP
- Master Data Management
- R
- Data Management
- Clinical Trials
- User Acceptance Testing
- Data Warehouse
- SAS
- Oracle
- Data Analysis Skills
