Clinical Data Management Project Lead Fresher's job

Area Of Responsibility

1. Employee is accountable for the quality of work performed.
2. Independently perform all work to meet DM Management and stakeholders’ expectations.
3. Assists and coordinates the activities of junior Data Management Staff to provide support to operational milestones and resource planning across all direct reports’ projects to meet high quality data delivery.
4. Responsible for the overall consistency and efficiency across all projects assigned as well as managed by the direct reporting staff. Supports and executes, all activities centered on development and maintenance of Data Management Plan (DMP), eCRF design, data collection, data retrieval, coding, and query management.
5. Accountable for the performance of effective key performance metrics management for all assigned and all direct reports’ projects.
6. Manages junior DM staff and supports projects undertaken by the direct reporting staff, including but not limited to administrative oversight for CV/JD/SOP completion and Timesheet/Time-offs submission and approval in a timely manner. Ensures adherence to corporate procedures and policies. Ensures all project related agreements are comprehensive, accurate and complete.
7. Demonstrates corporate core competencies at the management level; exhibits corporate values.
8. Reports on quality and performance metrics, including timelines, to DM Management. Participates in the organization and presentation of in-house and external training courses.
9. Works in strict adherence to SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP and local regulations.
10. Reviews, freezes and locks data in accordance with DM control documents for accuracy, completeness, consistency, and validity, generate and submitted queries as necessary to investigation sites, as well as the project team at large.
11. Produces and/or coordinates reports and listings for team reviews and DSMBs (Data Safety Monitoring Boards).
12. Codes medical terminology, such as Adverse Events, Medical History, and Concomitant Medications, as appropriate and if required.
13. Develops and coordinates to finalize third party vendor Data Transfer Plans (DTP) for electronic database load to and from the company.
14. Performs ongoing reconciliation, including but not limited to SAE/AE, Electronic Data Loads and third party data such as central lab, IRT, against the clinical database and tracks issues to resolution.
15. Following CDISC conventions, oversee and perform EDC build activities including database design specifications; eCRF design and annotation, generation of data edit checks and data validations and data transfer specifications.