Silpa Pattanaik
Bangalore
Summary
Versatile Clinical Data Manager with 6 plus years of core CDM experience (total 8 plus year work experience), adept at managing databases and ensuring proper collection of key information. Experience in working on various EDC data bases including, medidata RAVE classic, RAVEx, Oracle Inform. Well versed in CDISC guidelines SDTM & CDASH, ICH-GCP & 21CFR Part11.
Overview
9
9
years of professional experience
Work History
Senior Clinical Data Analyst
PAREXEL
Bangalore
08.2022 - Current
- · Working on a NEUROSCIENCE TA (indication: Huntington disease), Phase II study for database setup.
- · Writing edit specifications & performing UAT.
- · Preparing study documentations like eCRF Completion guidelines etc.
- · Working globally with DML, programmers, clinical data engineers.
Senior Clinical Data Coordinator
ICON PLC
Bangalore
09.2021 - 08.2022
- · I was involved in Postproduction change activities, which includes modification to the edit checks & their UAT.
- · Created EDS (external data specification) & performed their validation.
- · Created SAS listing specification, eCRF completion guidelines for a set up study.
- · In a conduct phase study, I was involved in Query management, eTMF filing, Listings review, SAE reconciliation, vendor reconciliation etc.
- · Involved in direct client calls/interactions for various matters (for timelines, eTMF filing, status update on study activities etc.).
- · Performed comprehensive data management operational activities on Oncology (Leukemia, Squamous cell carcinoma) & Women Health (Menopause) therapeutic areas.
Clinical Data Specialist
IQVIA
Bangalore
03.2019 - 06.2021
- · Served as a Data Operations Coordinator (DOC) for 3 or more protocols.
- · Performed comprehensive data management operational activities on Neurology (Alzheimer’s disease, Multiple sclerosis, amyotrophic Lateral sclerosis) therapeutic area.
- · Worked on data review, SAE reconciliation, Vendor reconciliations, Data transfer, Dataset review, Interim Analysis, Database lock activities, resolve data clarifications, all other associated activities and perform comprehensive quality control procedures for seamless delivery to the client.
- · Successfully handled 5 Interim Analysis (IA) and 4 database lock of the projects till now.
Clinical Data Associate
PPD
Bangalore
09.2016 - 03.2019
- · Involved in DM UAT of system edit check /Data validation checks & special listings / Procedure used as tools for data review & discrepancy management, EDC dataset QC activities.
- · Reviewing Protocol, eCRF guidelines & different study related documents to deliver accurate, clean & uniform data to clients.
- · Performed third party, SAE reconciliation tasks, Listings review & Manual review of EDC data.
Scientific Analyst
Molecular Connections
Bangalore
02.2015 - 05.2016
- · Involved in providing manually curated databases and informatics solutions to major pharmaceuticals, high throughput data analysts and systems biology companies across the globe.
Research Scientist
Regional Plant Resource Center, Government of Odisha.
Bhubaneswar
07.2013 - 11.2014
- · My research work focused on plant proteomics, ‘OMICS’- approaches to enhance fruit shelf-life in banana.
- · I have published my novel research findings in esteemed international journal “Horticultural Biotechnology Research”.
- · Article name: “A comparative method for protein extraction and proteome analysis by two-dimensional gel electrophoresis from banana fruit”
Education
PG Diploma - Advanced Clinical Research
Institute of Clinical Research India (ICRI)
2017
MSc - Biotechnology
Siksha 'o' Anusandhan University
2012
BSc - Biotechnology
Odisha University of Agriculture and Technology (OUAT)
2010
Skills
SKILLS:
- Client interaction, Query management, start up activities, UAT (edit check & database), Preparation of study documents like eCRF completion guidelines etc, Manual & SAS listing review, Study closeout activities, Vendor reconciliation, SAE Reconciliation, data quality review, Quality control of the study
- Sound knowledge on GCP, FDA EMEA regulations, MS office
- Therapeutic Area Explored:
- Oncology (Indication- Leukemia, Squamous cell carcinoma)
- Neurology (Indication- Alzheimer’s disease, Multiple sclerosis, amyotrophic Lateral sclerosis, Huntington disease)
- Women’s health (Indication - Menopause)
- Nephrology (Indication – chronic kidney disease (CKD))
Timeline
Senior Clinical Data Analyst
PAREXEL
08.2022 - Current
Senior Clinical Data Coordinator
ICON PLC
09.2021 - 08.2022
Clinical Data Specialist
IQVIA
03.2019 - 06.2021
Clinical Data Associate
PPD
09.2016 - 03.2019
Scientific Analyst
Molecular Connections
02.2015 - 05.2016
Research Scientist
Regional Plant Resource Center, Government of Odisha.
07.2013 - 11.2014
PG Diploma - Advanced Clinical Research
Institute of Clinical Research India (ICRI)
MSc - Biotechnology
Siksha 'o' Anusandhan University
BSc - Biotechnology
Odisha University of Agriculture and Technology (OUAT)
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