Nisha Devi M. Email & Phone Number
Who is Nisha Devi M.? Overview
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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.
Email format at AbbVie
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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.
Nisha Devi M.'s current company
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Nisha Devi M. work experience
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Senior Clinical Study Manager
Study Manager
Project Manager
- 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.
Project Manager- Contractor
Clinical Research Associate
Clinical Data Coordinator
- 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.
E-Clinic Analyst
- 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.
Colleagues at AbbVie
Other employees you can reach at abbvie.com. View company contacts for 46234 employees →
Sathya Shankar
Colleague at Abbvie
United States, United States
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IL
Inge Leblanc
Colleague at Abbvie
Greater Milwaukee, United States
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VM
Valerie Moody
Colleague at Abbvie
Sturtevant, Wisconsin, United States, United States
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MJ
Mary Jo Comerford
Colleague at Abbvie
Lake Zurich, Illinois, United States, United States
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HS
Hitesh Sumaria
Colleague at Abbvie
Mumbai, Maharashtra, India, India
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DE
Dina Elassaad
Colleague at Abbvie
Greater Paris Metropolitan Region, France
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SJ
Suraj Jayasheel Rao
Colleague at Abbvie
Raleigh, North Carolina, United States, United States
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SM
Shea Mclaughlin
Colleague at Abbvie
Pasadena, California, United States, United States
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JJ
Jacquelyne Jewer
Colleague at Abbvie
Canada, Canada
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YT
Yasr Turkman
Colleague at Abbvie
Damascus, Damascus Governorate, Syria, Syrian Arab Republic
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Nisha Devi M. education
Master'S Degree, Clinical Research Administration
Bachelor Of Technology (B.Tech.), Biotechnology
High School, Bio Maths
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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