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Looking for a career change in social or environmental sector post completion of M.Sc. in Ecology and Environment Studies at Nalanda University, Rajgir. I have 4.5 years of work experience in Clinical Data Management domain as Data Analyst at Accenture, Clinical Data Coordinator at Icon Clinical Research Pvt. Ltd. and Process Trainer at Cognizant. I am completing my course in August, 2016. |
 Contact Anshuman Shekhar
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Area of Expertise: |
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Capacity Building, Training, Advocacy
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Environment, Climate, Energy, Water, Sanitation
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Monitoring, Evaluation, Policy, Research
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Social, Gender, Education, Youth, Child
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Professional Experience: |
Oct, 2012 to Sep,2014: Cognizant Technology Solutions
Role: Process Trainer (April, 2014 to September, 2014); Jr. Process Trainer (October,2012 –March, 2014)
Delivering Process Trainings: Conducting training sessions for corporate and project Specific modules in Clinical Data Management; development of training modules, invigilation
during skill analysis assessments, conducting clarification sessions for associates and other related tasks for the project with a strength of around 450 Associates in 5 locations spread across India, USA and UK.
Auditing Training Records: Review of training records; helping the team prepare for client, third party and regulatory body audits, attending management meetings and give inputs regarding trainings and compliance
Training related assistance and management for the assigned project: arranging training sessions and related logistics for more technical modules, rolling out new developments in the process w.r.t., to training requirements or documentation, coordinating with process and client in preparation of training materials, discussion with operations management about applicability of different modules to different roles and finalization of training plans for the project, analyzing the requirements for introduction and removal of modules as and when required, coordinating between different processes.
Training Compliance: preparing compliance reports and driving compliance of trainings
across the project, attending skill gap analysis meetings held after QC reports publication and discuss and implement corrective actions required to bridge the gap, introduce new joiners to training plan for their roles.
Sep, 2011 to Sep, 2012: ICON Clinical Research
Role: Clinical Data Coordinator-I
Clinical Data Validation using OC-RDC, External Data Reconciliation, Management of
electronic Clinical Trial Master File, assisting team members in coordination, at times assisting training sessions.
Feb, 2010 to Sep, 2011: Accenture Services Pvt. Ltd.
Role: Senior Associate (CDM) (Jul, 2010 to Sep, 2011) Clinical Data Validation Associate (Feb, 2010 to Jun, 2010)
1)Therapeutic Areas and Clinical Phases: Worked on Phase-I, II, III and IV studies using InForm EDC in the therapeutic areas of Gastroenterology, Pulmonary, CNS/Neurology and cardiology.
2)Daily Routine: My daily work included review and re-review of patient data according to trigger points as indicated by Clean tracker prepared using InForm Reporting Tool; query management; running macros against database to perform listings and manual checks, updating production trackers, responsible for Capacity Utilization tracker for the Unit, responding to client and monitor requests, co-coordinating team work.
3)Reports and Analysis: Preparing and analyzing different reports, like page count report, query report, etc. using InForm and send relevant updates to the Project Lead and Team Members.
4)External Data Reconciliation: External data reconciliat
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Education: |
EDUCATIONAL PROFILE
2014-2016 Nalanda University M.Sc. Ecology and Environment Studies
Courses: 1st Semester: Understanding our Environment; Principles of Ecology; Environment & Society – Introduction to Key Concepts; Methodologies & skills in Environmental studies.
2nd Semester: Global Climate Change; Sustainable Development; Urban Ecology;
Pollution and Health; Environmental Issues: Conflicts & Choices.
3rd Semester: Water and Energy in Development Policies; Agroforestry; Environment, Technology and Society; Environment, Law and Governance;
Summer Internship.
4th Semester: Environmental Impact Assessment; Disaster Management; Global Asia;
GIS.
Result: Around 65% (average of the past 3 semesters).
2009-2010 Lotus Clinical Research Academy
Advanced PG Diploma in Clinical Data Management.
Courses: ICH-GCP, Declaration of Helsinki, Belmont report, Nuremberg Code, 21 CFR Part 11, GCDMP, CDISC, CRF, ICF Process, Overview of Clinical Research, CRF Designing, CDM Phases, Data Validation, Oracle Clinical, Electronic Data Capture, Medical Coding, O-TMS, O-RDC, Basics of SAS, e-CRF designing, writing data validation procedures, study design, using
Global Library, etc.
Result: Passed (Grade B; 65%)
2007-2008 University of Manchester
PG Certificate in Bioinformatics
Courses: Genomes to Systems, Introduction to programming using Java, Introduction to
Bioinformatics, Bio-computing, Theory and Algorithms in Bioinformatics
Result: Passed (45 Credits)
2004-2007 Bharati Vidyapeeth University
B.Sc. in Microbiology
Courses: 1st Year: Microbiology-I, Microbiology-II, Microbiology Practical-I, Chemistry-I,Chemistry-II, Chemistry Practical-I, Zoology-I, Zoology-II, Zoology Practical-I, Botany-I, Botany-II and Botany Practical-I.
2nd Year: Microbiology III, Microbiology IV, Microbiology Practical II, Chemistry III, Chemistry IV, Chemistry Practical II, Botany III, Botany IV, Botany Practical II and English.
3rd Year: V-Medical Microbiology, VI-Industrial Microbiology, VII-Microbial Metabolism and Biochemical Evolution, VIII-Clinical Pathology and Immunology, IX-Microbial Genetics and Genetic Engineering,
X-Applied Microbiology, Practical Papers-III, IV and V.
Result: 1st Year: 66.33%; 2nd Year: 72.1%; 3rd Year: 62.6%; Overall: 67.6%
2000-2002 Gyan Niketan (CBSE)
10 + 2
Courses: Biology, Chemistry, English, Mathematics (included Integral and Differential Calculus, Differential Equations, Algebra, Arithmatics, Geometry, Co-Ordinate Geometry, Probability, Permutations and Combinations, Sets and Functions), Physics
Result: 57%
1999-2000 Gyan Niketan (CBSE)
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Affiliations and Achievements: |
SKILLS
Clinical Data Management:
•Data Management, Query Management, External Data Reconciliation using EDC tool Inform and OCRDC.
•Attended sessions on CDM Software: Rave
•Experience in Data Entry using eCase Link and Oracle Clinical
•During PG Diploma course, learnt e-CRF designing, writing Validation Procedures, etc using Oracle Clinical.
EXTRA-CURRICULAR ACTIVITIES
•Got appreciation letters in school level competitions, awarded Certification in Accenture for Data Validation, got certification of appreciation for “pictorial representation of Protocol” and secured 3rd position for presentation of the team activity in intra-company competition.
•Regular participant in field trips, workshops, seminars and conferences.
•Secured A+ grade and All India Ranking: 78 in All India Level Mathematics and Science Test conducted by Central Institute for Proficiency in English Language (CIPEL) in school.
•I also participate in social events like Blood Donation Camps, to help the performers during Annual office fests, etc.
•Volunteered through CSR initiative at Cognizant to teach (English and Science) and conduct educational competitions in community school for kids of daily wage earners.
•Won awards for best Data Management Team at Accenture and Outstanding performance at Cognizant.
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Available for: |
- Job opportunities
- Internships / Fellowships
- Being headhunted – make me an offer
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Years of Experience:
2-5 years |
Highest Qualification:
Masters |
Languages:
English, Hindi |
Nationality:
Indian
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