Kailas Desai
Associate Clinical Data Manager - Pfizer
- Role
- Associate Clinical Data Manager (Clinical Data Science) at 화이자
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Kailas Desai
Highly skilled Clinical Data Manager with 4.5 years of experience in clinical research…
Experience
Associate Clinical Data Manager (Clinical Data Science)
Feb 2024 — Present · Mumbai, IN
Oversee data entry and ensure accuracy and completeness of clinical trial data.•Perform data cleaning and validation to ensure data integrity.•Monitor data for inconsistencies, errors, and missing information.•Conduct regular quality checks on data collected as per Data Management Plan•Ensure data complies with regulatory standards (e.g, FDA, EMA) and Good Clinical Practice (GCP) guidelines.•Manage all the eTMF documentation required for regulatory submissions.•Work closely with clinical research teams, Senior Data Manager, CDS, and Study team.•Coordinate with external vendors who are involved in the clinical Data Management process.•Summaries of clinical trial data and performed DRP, VC review & listing review. •Support Sr. Data Manager and CDS by providing clean and validated datasets as per DRP•Manage all data-related aspects of study conduct and close out including database locking and freezing activity.•Oversee the archiving eTMF documents of clinical trial data post-study completion.•Utilize specialized clinical data management software (e.g, Inform, DMW, Medidata Rave, Oracle Clinical, Vault eTMF, Impala, eRT, iRT, eCTS.
Education
MGV's Pharmacy College Nasik
Master of Pharmacy
2017 — 2019
Shree Mahavir Institute of Pharmacy
Diploma in Pharmacy
2012 — 2014
Mumbai Educational Trust, MET League of Colleges
Bachelor of Pharmacy - BPharm
2014 — 2017
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