Raghavendra Karanam
Manager Centralized Monitoring (RBQM) | Clinical Research Expert
- Role
- Manager Risk Management and Central Monitoring at 百时美施贵宝
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Raghavendra Karanam
At BMS, our team has sharpened the focus on study health, leveraging my expertise in…
Experience
Manager Risk Management and Central Monitoring
Jan 2025 — Present · Hyderabad, IN
Protocol De-risking Process involves identifying critical success factors and quality factors, including critical data and processes. Collaboration with various team members, such as the Data Management Lead, Statistician, Global Trial Manager, Quality Lead, Clinical Trial Physician, Clinical Scientist, etc. is essential to develop an initial proposal on Key Risk Indicators and Quality Tolerance Limits. This proposal should include information on critical data, data sources, data flow, data review frequency, and external data transfer frequency.• Collaboration and Leadership Leading and collaborating with the study team to develop specifications for setting up KRIs, Data Quality Assessments, and QTLs. Additionally, partnering with the DML and other data review functions to determine the holistic data review strategy for the study and document the Central Monitoring data analysis responsibilities in the Integrated Data Review Plan.• Additional Responsibilities These may be assigned by leadership and include support for the execution of Risk-Based Management processes as part of cross-functional teams spanning the DD portfolio.• Quality Oversight Effective quality oversight and management of external partners performing Risk Management or Central Monitoring activities on behalf of BMS is essential.• Metrics Development Developing and maintaining metrics to evaluate risk monitoring performance and effectiveness. Participation in initiatives, continuous improvement opportunities within the CORM and broader organizations is encouraged.• Risk Monitoring Regular risk monitoring at the study level is required, along with providing holistic risk reports at agreed frequencies. Emerging risks, including QTL deviations, must be escalated to the AD Risk Management and Central Monitoring for discussion at relevant governance bodies. Triggering new, previously open signals in preparation for Risk Review Meetings to prioritize signals for discussion, recommended actions.
Education
Ratnam Jr College nellore
+12, Biology, Chemistry, Physics
2003 — 2005
Medical University of South Carolina
Master of Science (MS), Clinical Research
2010 — 2012
The oxford college of science
Bachelor of Science (BSc), Biotechnology, Biochemistry, Genetics
2007 — 2010
ICRI Hyderabad Collaborated With Medical University of South Carolina (US) University
MS, Clinical Research
2010 — 2012
Skills
- Medical Writing
- Clinical Monitoring
- Clinical Trial Management System (Ctms)
- Clinical Research
- Ich-Gcp
- Regulatory Submissions
- CRO
- Lifesciences
- Clinical Development
- Edc
- Therapeutic Areas
- Ctms
- Electronic Data Capture (Edc)
- Clinical Data Management
- Gcp
- Good Clinical Practice (Gcp)
- Pharmacovigilance
- Clinical Trials
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.