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Ashwati Methil’s Emails [email protected]
Ashwati Methil’s Phone Numbers No phone number available.
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Ashwati Methil’s Location Trivandrum, Kerala, India
Ashwati Methil’s Expertise Experienced Principal Lead Clinical Data Manager with a demonstrated history of working in the pharmaceuticals industry for biosimilars. Over 12 years of experience as a healthcare professional spanning over Clinical data management and production of biosimilars. Sound knowledge across the various domains of clinical research and trials from production of bio similar drug for research and development to clinical data management of the clinical trials. Extensive experience in clinical data management within an ICH/GCP environment. Proven track record in leading multiple large & complex global oncology studies, Proficiency in end-to-end data management activities, including database design/UAT, third-party vendor management, central data review, and close-out. Experience in defining data strategies and data flows for complex trials involving multiple data sources. Familiarity with data structures such as CDISC CDASH and STDM. Significant experience using data reporting and review tools, including creating programming specifications. Excellent communication skills, with a history of collaborating with global, cross-functional teams and engaging directly with clients and vendors. Understanding of medical terminology and clinical trial methodology. Proven ability to proactively manage project budgets, timelines, and resources. Experience in preparing and leading client meetings, such as Site Initiation presentations and kick-off meetings. Strong planning and organizational skills, with the ability to work effectively under pressure. Exposure to Central/Risk-based Monitoring and Real-time data cleaning. Supported development of Artificial Intelligence and Machine Language in real time data cleaning within DM team. Set up and maintain data management study files ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory or internal Auditors.
Ashwati Methil’s Current Industry Iqvia
Ashwati
Methil’s Prior Industry
Biozeen
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Dr Reddys Laboratories
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Iqvia
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Work Experience

Iqvia
Principal Data Lead
Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Iqvia
Senior Lead Clinical Data Manager
Sat Oct 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
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Senior Clinical Data Lead
Mon Nov 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
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Clinical data lead
Sat Dec 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Nov 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
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Senior Clinical Data Coordinator
Sat Apr 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Dec 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
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Clinical Data Coordinator II
Fri Apr 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Apr 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
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Clinical Data Coordinator I
Wed Apr 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Apr 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
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Associate clinical data coordinator
Sat Feb 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Apr 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Dr Reddys Laboratories
Junior Manager
Tue Jun 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jun 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Biozeen
Trainee
Sun Nov 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Apr 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)