Sr. Executive-Clinical Data Management

Job Summary

The incumbent is responsible for effectively participating in the start-up and completion of multiple Data Management projects according to stakeholder requirements and in accordance to SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP and local regulations

Area Of Responsibility

1. Effective management of all data management aspects of assigned project(s) from setup to lock.


2. Attend regular meetings with project team, for discussions relating to data management issues and provides status updates for the project.


3. Report on quality and performance metrics, including timelines, to project leads and other stakeholders


4. Participate in in-house and external training courses, where required.


5. Participate in the preparation/review of Data Management process control documents, including but not limited to Data Management Plan, Data Edit Checks Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, Reconciliation plans, CRF Completion Guidelines, Coding Guidelines, etc.


6. Coordinate and manage training and EDC access for investigators, coordinators, data entry and CRAs on selected applications for data entry, cleaning, and running reports, as applicable to study parameters.


7. Review, freeze and/or lock data in accordance with Data Management documents for accuracy, completeness, consistency and validity, generate queries, as necessary, for sites and/or project team.


8. Coordinate with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required.


9. Maintain Data Management study documentation in an audit-ready status,


10. Perform reconciliation, including but not limited to SAS/AE, Electronic Data Files (EDF) and third-party data such as central labs and IVR, against the clinical database and track issues to resolution.


11. May present at investigator meetings and PM/CRA training sessions.


12. Identifies and recommends process improvements to management team, as identified.

Geographic Scope/ Market

Global

Budget (if applicable)

Work Conditions:

Full time

Physical Requirements:

Presence at work

Travel Estimate

Infrequent

Education and Job Qualification

Preferably a minimum of a Bachelors degree in a Life Science, Nursing, Computer Science or related discipline

Experience

Executive-Minimum 3 years of clinical data management experience including working knowledge using clinical data capture tool