Novartis Hyderabad Job Opening – BSc Life Science Apply Online
Novartis Hyderabad Job Opening – BSc Life Science Apply Online. Life Science candidates apply online for a Clinical Risk Manager- Process Improvement position that is available at Novartis. Novartis is hiring bsc candidates, as per the details below in their Research & Development area:
Job Title: Clinical Risk Manager- Process Improvement
Job ID: 292899BR
Location: Hyderabad, AP
Division: Global Drug Development
Business Unit: GDO GDD
Employment Type: Full-time
Job Description:
500+! That’s the number of clinical trials that our associates in Global Development Operations (GDO) support. Executing such a huge portfolio requires a very functioning process environment where risks arising from our processes are promptly identified as well as optimally mitigated. A number of these processes are cross-functional and need to be checked out from an end-to-end perspective. This is where the Clinical Risk Management group of the GDO Risk Management Office gets involved: we attend to the risks that gaps and deficiencies in our cross-functional processes cause in regards to quality as well as data integrity.
As a Clinical Risk Manager, you will certainly contribute to enhancing our cross-functional process environment in GDO with activities ranging from trending of process
risks & issues, identifying key root causes and developing process improvement solutions. In doing so, you will work in close collaboration with members from the various operational excellence groups in the different GDO line functions and also beyond.Your duties include, however, are not limited to:
- Adds to the development and also upkeep of a standard business process across GDO that focuses on triaging as well as reporting of systemic quality issues as well as risks to the appropriate escalation and also decision level. Adds to the development and also upkeep of an appropriate issue and also risk registry for systemic quality risk and also issue trends across GDO.
- Analyzes available data sources on potential, GDO-relevant, cross-functional, systemic quality risk as well as issue trends as well as performs a risk assessment considering at minimum frequency/likelihood of repeat occurrences and degree of impact. Brings results forward to GDO Quality Review Board (QRB) to agree on the route of action.
- Where the need for remediation is confirmed by GDO QRB, performs a data-driven root cause analysis to identify which areas specifically need to be improved to avoid repetition of cross-functional, systemic quality issues moving forward.
- Upon identification of key root causes of cross-functional, systemic risks and also issues, adds to cross-functional teams in identifying, planning and also implementing appropriate mitigation plans. Ensures that improvements are quantifiable and that effectiveness checks will be in place.
- Lines up with the process excellence groups across GDO as well as beyond (e.g. GDD, NIBR, GMA) to make sure that any kind of function-specific risk and also issue trends that were incidentally identified while reviewing and scouting data have been or will certainly be picked up by the respective functional group for further analysis and mitigation. Tracks development of mitigation plans and also their implementation for cross-functional risks as well as high-impact functional risks. Tracks whether improvement targets are met and also where not increase it for additional action.
- Adds to the development/ enhancement of GDO-wide key risk/ quality. Contributes to the development of feedback loops with GDO associates on identified systemic issues, risks and also planned mitigations to allow them to plan these into their own project plans.
Minimum requirements:
- Bachelor degree in life science, quantitative science or business Fluent in English (oral & written) with 3 – 5 years of experience in clinical operations
- 1 -2 years of experience in risk management, quality management, process improvement or related role
- Good understanding of the drug development process as well as ICH-GCP requirements.
- Experience with data mining/analysis, basic statistical methodologies in addition to root cause analyses. Ability to think independently as well as out of the box and also able to assess complex problems
- Great project management skills. Tested networking skills as well as capability to share knowledge and also experience amongst colleagues.
- Proven ability to work in a complex matrix environment (including remote or virtual team environment).
- Organizational awareness, including experience working cross-functionally as well as in international teams.
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