Job Description:
1. Provides DM leadership across assigned trial(s) Acts as the Trial Data Manager where needed
2. Demonstrates a business understanding of the compound(s) profile to identify and assist in successful application of data management processes.
3. Provides feedback to assure well written protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting and that do not make the best use of available standards.
4. Performs DM activities for start up of a study including preparing the eCRF, CCGs where needed, Data Handling plan (DHP), Data Review Plan (DRP) and performing user acceptance testing (UAT)
5. Manage local lab set up for the Clinical Database as applicable
6. Performs DM hands on activities during the course of the study
7. Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)
8. Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation
9. Supports and assists Junior staff for assigned trials
10. Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner
11. Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence
12. Tracks and reports status and progress for assigned trials, indications or programs. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks).
13. Ensures adherence to GCP, DM standards, SOPs/WPS and process guidelines
Key Performance Indicators:
1. Achieve overall goals as set each year by Global Head, Data Operations, GDO and Group Head, Data Management
2. All assigned project deliverables meet targets for quality, time and productivity in adherence with business standard operating procedures
3. No critical audit findings due to Data Management
Do let me know if you are interested in the opportunity by sharing Updated Resume along with the below details to abhishek.mario_jose_ext@novartis.com
