Vikash Sharma :Qualification : M.Sc. Clinical Research & B.PharmacyMobile : +91 – 9676643748Email : vikashsharma.cdm AT gmail.comOBJECTIVES :
With current experience of 4 years it is my strong passion to work in a research oriented environment and to pursue a challenging career in a progressive firm to achieve further refinement and enrichment of my knowledge and skills. I also endeavour to attain the cherished goals of the firm.PROFILE :
A global communicator, culturally sensitive and able to build strong working relationships at all levels. Quickly grasp new concepts and visualise the bigger picture. Very determined, logical, efficient and dynamic. Learning makes optimum use of my time and study diverse fields. I am a go getter, carry confidence, having positive attitude towards all challenges.EDUCATION SNAPSHOT :
M. Sc. (Clinical Research) Cranfield University/ICRI, New Delhi 2010 1st
B. Pharmacy Maharishi Dayanand University, Rohtak (HR.) 2004 1st
12Th CBSE 2000 1st
10Th CBSE 1998 1stWORK EXPERIENCE :
PAREXEL International Ltd (07th Jan, 2013 to Till Date)Job Function : Clinical Data Analyst I (CDA I)SBU/Division : CDMResponsibilities :
1. Utilize current study documentation including protocol, Case Report Forms (CRFs), cleaning guidelines etc.
2. Conduct in-house data review
3. Generate and close queries or apply self-evident corrections to the data according to the relevant guidelines
4. Identify and report protocol violations
5. Train team members on selected tasks
6. Manual and Patient Profile review, issue queries
7. Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action
8. Track and integrate queries
9. Perform clinical coding if appropriate to role within the project team
10. Ensure all documents coded for submission to central files
11. Lock site(s) within EDC system - remove user's data modification privileges
12. Interact with site (via mail) as required
13. Perform early and final database QC activities
14. Update all relevant tracking system on an ongoing basis
15. Inform responsible CDA coordinator of work status regularly
16. Keep manager informed about work progress and any issues to avoid surprises. Requires regular interaction / supervision by Manager or assigned mentor.
17. Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims.Cognizant Technology Solutions : (07th Jul, 2012 to 02nd Jan, 2013)Job Function : Junior Data Analyst (Medical Coding)SBU/Division : CDMResponsibilities :
1. Sponsored links :
Ensure consistency of coding across and within projects with particular emphasis on adverse events.
2. Manually encode medical and therapy terms not automatically encoded by the CDMS using MedDRA and WHO-DDE dictionaries.Max Neeman Medical International Ltd. : (1st April, 2012 to 29th Jun, 2012)Job Function : Validation AssociateSBU/Division : CDMResponsibilities :
1. Query Management
2. Preparation of DVP and ECS
3. Check Testing for database
4. Database Screen Testing
5. SAE ReconciliationMax Neeman Medical International Ltd. : (1st April, 2011 to 31st Mar, 2012)Job Function : Process AssociateSBU/Division : CDMResponsibilities :
1. Project coordination for EDC as well as paper studies
2. Data Entry in First pass as well as Second pass.
3. Edit Check testing in database
4. Database Screen testingPatni Computer Systems Limited : 3 Months (03rd May, 2010 to 23th Jul, 2010)Job Function : Project Trainee (Contractor)SBU/Division : Life Sciences (Medical Coding)Responsibilities :
1. Perform medical coding using MedDRA and WHO-DDE dictionaries.HAND ON EXPERIENCE TO WORK ON THE FOLLOWING PROJECTS :
S. No. Therapeutic Area Clinical Trial Phase
1 Dermatology III
2 Endocrinology III
3 Respiratory IIIIT SKILLS :
1. Inform (v 4.6)
2. SAS (Statistical Analysis System) Pheedit (v3.01,v 3.03 v3.3 & v4.10)
3. MS Office (Word, Excel and PowerPoint & MS Access)PRACTICAL APPROACH :
1. Schedule Y
2. Principles of ICH-GCP Guidelines.
3. US FDA
4. Code for Federal Regulations.
5. Good Manufacturing Processes (GMP).
6. Clinical Data Management Processes
7. Safety Data Management, SAE Reporting and Reconciliation.
8. Pharmacology (Pharmacokinetics and Pharmacodynamics).
10. Informed Consent Process.PERSONAL SYNOPSIS :DATE OF BIRTH :16 – Dec - 1982GENDER : MaleMARITAL STATUS :UnmarriedPASSPORT : YesPRESENT ADDRESS :
Flat no. 402, 4th Floor, Bhanu Towers,
Arunodaya Colony, Madhapur; Hyderabad-500081PREFERRED LOCATION :Anywhere in India.Date :Place :
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