ARUNKUMAR N
Coimbatore,TN
Summary
To enhance my creativity & innovative skills in a challenging atmosphere and to Strive hard in achieving the goals of the organization.
Overview
1
1
Language
Work History
Data Entry Clerk
CDM, Quanticate International Ltd
- Bangalore from Oct 2016 to May 2017.
- Working as a Clinical Research Coordinator – Report Writing in Spinos life science and research Pvt ltd., Coimbatore from Nov 2018 to till now.
- Undergone various training in Spinos Life Sciences regarding clinical trials, ICH-GCP and various regulatory requirements like USFDA, EMA, ANVISA, Canada, China, DCGI etc,.
- Involved in more than 50 BA/BE Studies.
- Responsibilities:-.
- Data entry of clinical trial data into database with accuracy and speed.
- Tracking and entry of Case Report forms (CRFs).
- Identification of data issues during first and second entry and recording/reporting it on the specified spreadsheet.
- Knowledge on ORACLE, RAVE database entry level, Source data validation, Listings review, Quality Control and Review, comparison Reconciliation in Clinical Data Management.
- To assist Report writing team in the preparation of clinical trial department.
- Preparation of Study Report [Clinical, Bio-analytical and Clinical Trial] as per the applicable regulatory requirements like CTD, eCTD etc.,.
- Finalizing the report with eCTD specifications to follow E3 guidelines as per various regulatory guidelines (USFDA, EMA, ANVISA, Canada, China and TPD).
Education
Advanced Diploma - Clinical Research and Clinical Data Management
Syncorp Clincare Technologies (P) Ltd
B.Tech - Biotechnology
Kamaraj College of Engineering & Technology
XII - undefined
Nadar Higher Sec. School
X - undefined
Nadar Higher Sec. School
Accomplishments
- Good practical knowledge in (RTF, HTML, PDF, EXCEL).
- Basics and terminologies of CR, ICH GCP guidelines and regulations.
- CDM process flow, CDISC, 21 CFR Part 11.
- CRF Design, Database design and validation.
- Data Entry & Data Validation SAE Reconciliation and Database Lock.
- Clinical Study Report, Clinical Trial Report Bioanalytical Report and Method Validation Report AREA OF INTEREST:.
- Clinical Research and Clinical Data Management.
Timeline
Data Entry Clerk
CDM, Quanticate International Ltd
Advanced Diploma - Clinical Research and Clinical Data Management
Syncorp Clincare Technologies (P) Ltd
B.Tech - Biotechnology
Kamaraj College of Engineering & Technology
XII - undefined
Nadar Higher Sec. School
X - undefined
Nadar Higher Sec. School
Similar Profiles
Chandana Sri KChandana Sri K
Statistical Programmer-II at QuanticateStatistical Programmer-II at Quanticate
Steven LombardiSteven Lombardi
Sales Administrator at CDM IncSales Administrator at CDM Inc
Daniel HosciloDaniel Hoscilo
Transportation Engineer at CDM SmithTransportation Engineer at CDM Smith
SELVARAJ RANGASAMYSELVARAJ RANGASAMY
Planning Engineer at Evergreen Construction Pvt LtdPlanning Engineer at Evergreen Construction Pvt Ltd
Tejasweni KarthikeyanTejasweni Karthikeyan
English Trainer at Kshitiksha FoundationEnglish Trainer at Kshitiksha Foundation