Title:  Sr. Executive, Clinical Data Management

Job Summary

The incumbent is responsible for effectively supervising junior Data Management staff as well as the quality of work
performed for all studies. Wider responsibilities include in-depth understanding of stakeholder expectations and
project deliverables, providing and maintaining vendor relationships on behalf of the company and for the department.
The Data Project Lead will continue to perform as a Lead Data Manager on multiple global/local studies and will act as
a line supervisor.

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