Senior Data Manager
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Job Location:
Monthly Salary:
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
The Senior Data Manager will be responsible for oversight of all data management activities in large complex studies.
Communication
- Provide general oversight on all Data Management activities on large complex global studies
- Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting
Data Management
- Coordination of 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.
- Primary responsibility for clinical data management activities within clinical projects including but not limited to:
- Reviews and approvals escalation point and troubleshooting
- Involved in audits and inspections
- Supporting with SOP development and process improvements
- Provide input into Proposals Budgets and Bid Defense meetings
- Clinical database lock
- Coordination and supervision of processing dispatch and archiving of CRFs/queries
- Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol
- Development of CRF completion guidelines
- Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background additional training required)
- Electronic data transfer (import/export) specifications review and approval
Quality Control
- Database QC checks performance and documentation
- Shared responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data Management
- Shared responsibility for follow-up on and resolution of audit findings pertaining to Data Management
Training
- Training junior members of the team
- Project-specific training of investigators and clinical team in CRF completion
Qualifications :
- College or University degree or equivalent combination of training and experience that presents the required knowledge skills and abilities
- Significant experience of full scope of data management responsibilities in international EDC studies
- Experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)
- Organizational and managerial skills
Additional Information :
Advance your career in clinical research and develop new skillsets whilst growing with the organization.
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- SQL
- Data Collection
- GCP
- Master Data Management
- R
- Data Management
- Clinical Trials
- User Acceptance Testing
- Data Warehouse
- SAS
- Oracle
- Data Analysis Skills
About Company
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 effo ... View more
