Required for Program Clinical Data Manager at Novartis

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post : Program Clinical Data Manager

Job Description
- Provides DM leadership for one or more programs.
- Demonstrates a business understanding of the compound profile to identify and assist in successful application of data management processes.
- Develops strong program level standards (e.g. Protocols, DHPs/DRPs & eCRFs/CCGs) and assure adherence across trials.
- Develops a Working understanding of Database design principles and technology plat-forms under use.
- Develops an understanding of the CDISC or other recognized standards and how these impact the Programming Team. -Contributes effectively to development of new CRF standards and accompanying metadata, validations, CCGs etc.-Communicates and negotiates persuasively with other Program Level team members in all activities associated with development of program level standard. -Supervises the study start-up, conduct & finalization for Data Management activities. -Demonstrates effective application of knowledge across a wide range of DM scenarios (in-out-sourced, Paper, EDC, IIT, multi-armed etc.) -Manages effective execution of DM activities across one or more programs managing key issues that have been escalated for resolution across trials or by Program. Consistently and efficiently monitor for data trends that would be signals of potential fraud/misconduct, previously unrecognized quality concerns, or a sign of slippage in some aspect of study management. Ensures appropriate tracking systems are kept up to date. Manages communication of program wide DM status at Clinical and BDM Leadership team meetings. Supervises and drives the overall timelines/DM activities across one or more programs. Primary point of contact for DM at the Global Program Team. -Responsible for training and mentoring of new colleagues. -Provides the ongoing training and development of direct reports (if applicable). -Supervises individual contributors. Efficient use of resources (and resource estimation) through operational effectiveness and driving continuous improvement along with other Program Clinical Data Managers. Ensures DM associates on the program(s) are aware of the risks, priorities, goals, and impact of the work contribution.

 

Candidate Profile :
Timely and high quality completion of Data Management deliverables according to established objectives. University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree. Fluent English (oral and written). Ideally 8 years’ experience in drug development with at least 7 years in Clinical Data Management At least 2 years' Project Management experience (indication or program level) and demonstrated leadership ability Strong technical and problem solving skills Excellent understanding of clinical trials methodology, GCP and medical terminology

Additional Information:
Job ID:  213055BR
Experience: 2 years
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
Location:   Hyderabad
End Date: 10th August, 2017

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