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Nisha Devi M. Email & Phone Number

Study Management Associate II at AbbVie
Location: Vernon Hills, Illinois, United States 8 work roles 3 schools
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Current company
Role
Study Management Associate II
Location
Vernon Hills, Illinois, United States
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Who is Nisha Devi M.? Overview

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Quick answer

Nisha Devi M. is listed as Study Management Associate II at AbbVie, a company with 46234 employees, based in Vernon Hills, Illinois, United States. AeroLeads shows a matched LinkedIn profile for Nisha Devi M..

Nisha Devi M. previously worked as Senior Clinical Study Manager at Icon Plc and Study Manager at Icon Plc. Nisha Devi M. holds Master'S Degree, Clinical Research Administration from Eastern Michigan University.

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Email format at AbbVie

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AbbVie

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Profile bio

About Nisha Devi M.

As a Clinical Study Manager with over 9 years of experience in clinical research operations, I have successfully managed the study build team and delivered high-quality and timely results for various clients, including AbbVie. I have a master's degree in clinical research administration from Eastern Michigan University.I have extensive knowledge and skills in IDBS E-Clinic Services, Clinical Trial Administration, Regulatory Affairs, Bioinformatics, and Biotechnology. I have also demonstrated my proficiency in LIMS, 21 CFR Part 11, HIPPA, and ICH guidelines. My mission is to contribute to the advancement of clinical research and innovation by applying my expertise and passion for excellence and collaboration.

Current workplace

Nisha Devi M.'s current company

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AbbVie
Abbvie
Study Management Associate II
north chicago, illinois, united states
Website
Employees
46234
AeroLeads page
8 roles

Nisha Devi M. work experience

A career timeline built from the work history available for this profile.

Study Management Associate Ii

Current

Chicago, Illinois, United States

Nov 2024 - Present

Senior Clinical Study Manager

Apr 2022 - Oct 2023

Study Manager

Illinois, United States

Aug 2020 - Apr 2022

Project Manager

Greater Chicago Area

  • Client- Abbvie
  • Requirement specification gathering, documenting the requirements, hosting PoC demos, testing the delivered templates before the UAT using IDBS E-Workbook 10.4, IDBS E-Inventory 2.1, LIMS and Dotmatics.
  • Expert on Discovery/Pre-clinical/Clinical data, Requirements Management, Design, Development, Testing and Configuration Management.
  • Managing the study build team – held key responsibility of deliverables – with respect to Quality and timelines.
  • Strong knowledge of Laboratory Information Management System (LIMS) that is required to complete job responsibilities.
  • Good understanding and adherence with the SOPs, Guidelines and Work Instructions appropriate to the job function.
Jan 2019 - Jul 2020

Project Manager- Contractor

Jan 2019 - Jul 2020

Clinical Research Associate

Novi, Michigan

Nov 2015 - Jan 2019

Clinical Data Coordinator

Detroit

  • Conducted activities of clinical research protocols including obtaining informed consent, reconsent, subject enrollment, subject eligibility criteria validation, maintaining patient charts
  • Maintaining data integrity by ensuring data entered in case report forms are accurate.
  • Responsible for Informed consent development, and its amendment.
  • Responsible for submitting regulatory documents to WIRB like initial study approval, study amendments, annual continuations and terminations.
Apr 2014 - Sep 2014

E-Clinic Analyst

Chennai Area, India

  • GCP, 21 CFR Part 11, CDISC, SDTM, CDASH standards.
  • Act as quality control programmer to validate SAS programs that produce derived/analysis datasets and analyses specified in the Statistical Analysis Plan.
  • Optimized performance using Data Validation and Data cleaning on Clinical Trial data.
  • Imported huge data in to SAS library and sorted according to the class of the drug using ORDER BY option.
  • Knowledge of regulation such as CDISC SDTM and ICH guidelines, also ADaM implementation of standardization for the analysis dataset.
  • Expertise in designing workflows using E-Workbook/ BioBook ELN product for Novartis, IDBS, Roche, Biogen Idec clients.
May 2012 - Mar 2013
Team & coworkers

Colleagues at AbbVie

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3 education records

Nisha Devi M. education

Bachelor Of Technology (B.Tech.), Biotechnology

P.S.R.Engineering College

High School, Bio Maths

Kendriya Vidyalaya
FAQ

Frequently asked questions about Nisha Devi M.

Quick answers generated from the profile data available on this page.

What company does Nisha Devi M. work for?

Nisha Devi M. works for AbbVie.

What is Nisha Devi M.'s role at AbbVie?

Nisha Devi M. is listed as Study Management Associate II at AbbVie.

Where is Nisha Devi M. based?

Nisha Devi M. is based in Vernon Hills, Illinois, United States while working with AbbVie.

What companies has Nisha Devi M. worked for?

Nisha Devi M. has worked for Abbvie, Icon Plc, Zifo Rnd Solutions, Ascension, and Karmanos Cancer Institute.

Who are Nisha Devi M.'s colleagues at AbbVie?

Nisha Devi M.'s colleagues at AbbVie include Sathya Shankar, Inge Leblanc, Valerie Moody, Mary Jo Comerford, and Hitesh Sumaria.

How can I contact Nisha Devi M.?

You can use AeroLeads to view verified contact signals for Nisha Devi M. at AbbVie, including work email, phone, and LinkedIn data when available.

What schools did Nisha Devi M. attend?

Nisha Devi M. holds Master'S Degree, Clinical Research Administration from Eastern Michigan University.

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