Poornima N. Swamy is seeking a challenging position in biotechnology to utilize her 2.5 years of experience as a network support engineer and her M.Sc. in Biotechnology. She has skills in techniques like SDS-PAGE, DNA isolation, ligation, and transformation. She is pursuing a PG diploma in clinical research and has expertise in areas like clinical trials, clinical data management, pharmacovigilance, and medical writing. She has experience working as a trainee network support engineer and science faculty.
Laboratory, medical and device performance and validation following regulator...GlobalCompliancePanel
Too often, we focus on getting things done and results and miss working on our self-development. Let's face it: this is how we get paid yet this is also how we keep falling behind when it comes to our careers. It's time to get ahead! Don't miss an opportunity to advance as a manager again!
Laboratory, medical and device performance and validation following regulator...GlobalCompliancePanel
Too often, we focus on getting things done and results and miss working on our self-development. Let's face it: this is how we get paid yet this is also how we keep falling behind when it comes to our careers. It's time to get ahead! Don't miss an opportunity to advance as a manager again!
Laboratory, Medical and Device Performance and Validation following Regulator...GlobalCompliancePanel
This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control.
Hi,
Thank you for visiting my resume page.
This is my profile for a quick glance for recruiters.
If there is any relevant Job opening feel free to reach me.
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Elizabeth
The 10th Annual Utah Health Services Research Conference: Recommendations for Transparent Reporting of Data Quality Assessment Results for Observational Healthcare Data By: Lucy A Savitz, Ph.D., MBA
Health Services Research Conference: March 16, 2015
Patient Centered Research Methods Core, University of Utah, CCTS
Laboratory, Medical and Device Performance and Validation following Regulator...GlobalCompliancePanel
This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control.
Hi,
Thank you for visiting my resume page.
This is my profile for a quick glance for recruiters.
If there is any relevant Job opening feel free to reach me.
Thanks,
Elizabeth
The 10th Annual Utah Health Services Research Conference: Recommendations for Transparent Reporting of Data Quality Assessment Results for Observational Healthcare Data By: Lucy A Savitz, Ph.D., MBA
Health Services Research Conference: March 16, 2015
Patient Centered Research Methods Core, University of Utah, CCTS
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Associate, I have worked for major client sites such as PWC, Deloitte, ITC Infotech (payroll Data-Core Systems Inc.) during my career. Until recently, I led web data associate, in this role 1.6 years experience in a directory listing website, to add listing data to these directories with the application of WordPress, and Maintaining Dashboard optional features also active social networking websites.
• A competent professional with an experience of 11.5 years in:
Clinical Database Programming Data/Team Management Clinical Research
Process Improvement Coordination & Liaison Project Management
• Currently designated as Lead Engineer 2 – with Pure Software Solutions and working as Project Consultant for the client, Oracle, Hyderabad.
• Diverse experience of working for world’s leading pharma companies and strong knowledge of best practices followed across these companies for Clinical Data Management
• Deft in interpreting & communicating required information to facilitate decision making process of the top management
• Experienced in planning & executing data capture and management tasks in a timely / accurate manner to ensure high level quality & productivity of Clinical Data Management
• Skilled in effectively managing documents for streamlining systems to facilitate achievement of organizational objectives
• Proficient at carrying out Clinical Research beyond established markets
• Effective at building & maintaining relationships with the stakeholders and with a quick TAT of their queries
• Possess excellent communication, innovative, planning, negotiation, analytical and problem solving skills
• Goal settings, appraisal discussions and identifying key development areas for Team Leads and their respective team members.
• Ensure that all the projects are implemented successfully, by reviewing documents and sending instructions to the implementation engineers for successful installation of project in Customer environment.
Resume for the post of Data Manager in Clinical Data Managements Department.
I am having more than 7 years of experience and looking forward for a job opportunity in the Delhi-NCR or for home based job.
Madhavi Kaushal
Mob. No:+91-8447133946.
1. Poornima. N. Swamy
Cell No: 9620047274
Email: Poornimaswamyn@gmail.com
Objective
Seeking a challenging position to utilise my skills to the optimum level and also to enhance my
knowledge in the field of Biotechnology.
Profile :
2.5 years of experience as a network support engineer and was responsible for making
monthly reports, vendor management, single point of contact and responsible for managing
the R&R activities and bills, meeting customer TAT.
Accented with the latest trends and techniques of the field, pursued M.Sc ( Biotechnology)
from Sikkim Manipal University with an inborn determination to carve a successful career.
Gained practical exposure during training at Azyme Bio sciences .
Qualification:
Techniques Known:
SDS- PAGE and its restriction digestion, DNA isolation and its restriction digestion from sources
like plant, Bacteria.
Ligation of fragmented DNA
Double diffusion, Bacterial transformation.
Project: A report on DNA isolation from medicinal plants and DNA amplification.
Degree University Year Percentage
PG diploma in
Clinical Research
Avigna Clinical Research
Institute, Bangalore
2016 Pursuing
M.Sc Biotechnology Sikkim Manipal University,
Bangalore
2014 70%
B.Sc Microbiology SJRCW, Bangalore
University
2005 60%
P.U.C Vijaya College, Bangalore 2001 48%
S.S.L.C St.Theresa's School,
Bangalore
1999 68%
2. Additional
Advanced Diploma in Clinical Research
Technical Competencies:
Clinical Trials:
ICH-GCP, Site Selection, Site Initiation, Terminologies, Schedule-Y, ICMR Guidelines
Phase I, II, III & IV trials, Responsibilities of Monitor, CTA, CRA, CRC, Investigator, Sponsor,
Protocol, Investigational Brochure, CRF, e CRF
Recruitment and Enrolment, CRF Completion and Submission,
Data Query Degeneration and Resolution, Good Understanding of Regulatory guidelines in CR
Clinical Data Management:
Electronic Data Capture
CRF designing, Validation, Clinical Data Management (Process Flow),
Data Collection, Data Load/Transfer,
Data Storage, Data Validation, SOPs and Audits,
Query resolution. Oracle Clinical® overview, EDC, 21 CFR part 11,
Database design, Data entry and data collection including Data transfer.
Pharmacovigilance:
ADR, Serious Adverse Reaction, SAE, Med DRA, Risk Management,
Pharmacovigilance role, adverse drug reaction, SUSAR, ICH guidelines and Schedule Y,
Adverse event reporting –(med watch form),
Case process unit/ data entry( triage unit)/ Case assessment
Medical Writing:
Safety Writing, Regulatory Writing, Clinical Writing.
Clinical Research Internship:
Duration : Six Months
Professional Experience:
Trainee network support engineer (April 2009-Dec 2011)
Tejas Networks India Ltd -Bangalore
Science Faculty (May 2015 -July 2016)
Ravindra Bharathi Global School- Bangalore
Key Skills
Excellent communication and writing skills with the ability to do multi tasking under pressure.
Ability to plan, deliver innovative concepts quickly.
Ability to work with a fast pace, deadline-driven environment
3. Personal Details:
DOB : 09-09-1983
Marital Status : Married
Languages Known : Kannada, Hindi, English
Interests And Hobbies : Carnatic singer, Carrom,
Permanent Address : T.F.1,Kovela Homes, 7th main,17th cross, BTM 2nd stage,
Bangalore-560076
Place: Bangalore ( )
Date: