Unifers.ai

Subhash Amrutham

Clinical Data Management || Project Management || Clinical Data Standards Skills (CDISC/SDTM) || Data Analytics || SAS Programming Skills

Role
Principal Data Standards Analyst at Sanofi
Location
Hyderabad, TG, IN
LinkedIn followers
500 followers
OtherView LinkedIn profile

About Subhash Amrutham

A Clinical Data Management Professional with 15+ years of experience in Clinical Research (Pharma, CROs, BPOs) Industry.* Experienced in CDM, Clinical Data Analytics, Clinical Data Standards (CDISC/SDTM), Trial Overview Management, Stake Holder Management, Project Management, Regulatory and Client Audits, Client Interactions, Bid Defence Meetings, Budgeting, Resourcing, Leading and Mentoring Team.* Lead all phases of Clinical Data Management \"Study Set up, Study Conduct and Study Close out\".* Handled multiple studies at a time for different therapeutic areas.* Broad experience on Oncology, Neuroscience, Cardio Vascular, Muscular-Skeletal, Dermatology Therapeutic areas.* Overall knowledge of complete process flow in Drug Development, Clinical Research, Clinical Data Management, Competitive Intelligence.* Exposed to InForm, Medidata Rave, Oracle Clinical, Clintrial, Data Labs, other inhouse EDC tools for Clinical Data Management, Veeva for documentations/eTMFs, BI for Reporting/customized reporting, AI enabled tools to project KRIs, Jira for reporting Issues/Risks in the projects etc.* Have good exposure to SQL, Spot fire, and Base SAS.* Excellent managerial skills with ability to handle a team of expertise.* Highly committed towards assigned work.* Ability to work independently and manage time appropriately.* Good negotiation, Project Management and decision-making skills, Hard working, Passion to learn new things.

Experience

  1. Principal Data Standards Analyst

    Sanofi

    Jun 2025 — Present · Hyderabad, IN

Education

  • Sikkim Manipal University - Distance Education

    MBA, Project Management

  • Ekashila High School

    SSC

  • New Science Degree & PG College, Hunter Road, Hanamkonda, Warangal

    Bachelor's degree, Biotechnology, Microbiology and Chemistry.

  • SV Junior College

    Intermediate/12th Standard, Biology, Physics and Chemistry

Skills

  • Management
  • Clintrail Cdms
  • Clinical Data
  • Data Entry
  • Electronic Data Management
  • Edit Check Writing
  • Clinical Data Management
  • Oracle Clinical
  • 21 Cfr Part 11
  • Inform
  • Rave Cdms
  • Oracle Clinical Cdms
  • Sop
  • Inform Cdms
  • User Acceptance Testing
  • Ich-Gcp
  • Uat
  • Clinical Trials
  • Clinical Research
  • Discrepancy Management

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.

Start for freeSee how it works

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.

Subhash Amrutham — Principal Data Standards Analyst at Sanofi in Hyderabad, TG, IN | Unifers