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Sai Kumar Makka

Clinical Data Manager // Clinical Data Analyst // Clinical Data Coordinator // Pharmacologist // Registered Pharmacist // Patent Holder // Goal Digger 🎯🥇

Role
Clinical Data Manager i at Imaging Endpoints
Location
Hyderabad, TG, IN
LinkedIn followers
500 followers
Healthcare & Human ServicesView LinkedIn profile

About Sai Kumar Makka

Globally Experienced Clinical Data Manager, Data Coordinator and Data Analyst with demonstrated history of work experience in CRO, iCRO, and Pharmaceutical industry. Therapeutic area\'s of Experience: Oncology, Neurology, Immunology, Cardiology and Endocrinology.DM Experience in various Clinical trial Phases:Phase I, II, and BA/BE Studies (PK, PD, Bioavailability & Equivalence)- Generic Products. Skilled in Electronic Data Capture (EDC) Software\'s like Medidata RAVE - X, RAVE Classic, and CLINDEX Clinical Database systems. worked with Medical imaging and analysis softwares like Mint 3.7 and Mint 3.2.3.( CT, MRI, PET, and Bone Scans - DM QC & Adjudications )3. Experienced in all Clinical Data Management activities from Study setup to data base lock. worked with eTMF filing software\'s like ICO master, BOX, Veeva Vault and Master Control. Study specific Audit preparation & QC.4. Familiar with Good Clinical Practice (ICH-GCP - E6), post production change management, Study Status & metrics preparation, DVS/ECS, ALS/eCRF Spec, DTS/DTA, CCG, UAT - Screen testing and Edit check testing, CDISC Stnds, DMSS - Study access Requests processing, Base SAS 9.4, AI - Chat GPT, DRT - Data Review tool, TIBCO Spotfire, MS Excel 2021, MSB, Docu sign and 21 CFR part 11 guidelines. Strong information technology and Pharma professional with Master of pharmacy focused in Pharmacology - First class with distinction from Acharya Nagarjuna University.Pharmacologist Experience:Drug development, Drug ADME Properties, Adverse effects, Practical Preclinical Screening Methods, INDA, NDA, IRB, ICH - QSEM Guidelines, Laboratory Animal Handling and Care - SD Rates, Mice, Rabbits, Frogs and guinea pigs, and Lab Sample Collection.Test Result Analysis Methods - UV, IR Spectroscopy, Electronic Microscopy, Flow cytometry and Biostatistics methods.

Experience

  1. Clinical Data Manager i

    Imaging Endpoints

    Feb 2026 — Present · Hyderabad, IN

Education

  • Acharya Nagarjuna University

    Bachelor of Pharmacy - B.Pharm

    2013 — 2017

  • Chalapathi Institute of Pharmaceutical Sciences, Lam

    Master's degree

    2017 — 2019

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