Bhavani R. has over 9 years of experience in clinical data management. She currently works as a Clinical Data Coordinator II at ICON Clinical Research, where her responsibilities include serving as study lead, mentoring staff, performing quality reviews, and ensuring data accuracy. Previously she held roles as a Senior Clinical Data Analyst at Syngene International and as a Senior Clinical Data Coordinator and Clinical Data Coordinator at Quintiles technologies, where she gained experience in tasks such as database design, query management, and data validation. She has worked on several clinical trials across various therapeutic areas and phases.

1. BHAVANI R.
#2, Ground floor, ‘A’ block,
Annai Gardens, Ambal nagar, Pallikaranai
Chennai,
Tamilnadu – 600100 Mbl.No:+91-99947 31062
India. +91-74117 13943
Email: bhavsbhavani@gmail.com
PERSONAL AMBITION
To establish my talents and skills in a leading organization, that would pave the way for
consistent hierarchical development of the organization and my career.
EMPLOYMENT HISTORY
Name of Employer : ICON Clinical research
Date of Employment : 09Jul2015 till present
Job Title : Clinical Data Coordinator II
Business Title : Clinical Data Management
Key Responsibilities :
 Serve asa studyleadrole.RepresentData Management at internal / external
meetings as appropriate.
 Effectively mentor less experienced staff. This may include assisting and
guiding new personnel during their initial training period.
 Development, review and the update of relevant Data Management Study
Specific Procedures.
 Prepare database testdocumentationandtestdataentry screens. Assist with
the validation of edit check programs.
 PerformSeriousAdverse Eventreconciliationinaccordance withall applicable
procedures.
 Perform external data reconciliation in accordance with all applicable
procedures. Generate, review for accuracy and distribute status reports as
requested.
 Perform Quality Reviews and address all issues.
 ReviewCase ReportFormdatafor completeness, accuracy and consistency in
accordance with all applicable procedures, Generate data queries to resolve
data discrepancies. Addressresponsestodataqueries and update the clinical
data as necessary.
 Accurately and consistently apply data handling conventions to Case Report
Forms as necessary in accordance with all applicable procedures.
 Compile anddistributenecessarystudydocumentationandmaintainaccurate
and complete study files in accordance with all applicable procedures.

2.  Identify and address data discrepancies in the clinical data via computerized
edits and manual checks/listings.
 Identify and resolve all workflow or clinical data discrepant issues.
Name of Employer : Syngene International-a Biocon company
Date of Employment : 3Nov2014 till 04Jun2015
Job Title : Senior Clinical Data Analyst
Business Title : Clinical Data Management
Key Responsibilities :
 Mentoring data analysts and data entry associates
 Designing CRFs based on protocol
 Annotating paper/eCRFS
 Designing front end and back end database for EDC and paper based
trials
 Prepare and review the data management plan
 Prepare and review CRF filling guidelines if required
 Preparation of edit checks
 Performing query management
 Acts as a data quality reviewer, upon delegation for specific studies
 Prepare and review standard operating procedures
 Interfacing with QA department for audits
 Maintaining the study folder with all relevant documentations
Name of Employer : Quintiles technologies Pvt ltd, Bangalore
Date of Employment : Apr-2014 to 20Oct2014
Job Title : Senior Clinical Data Coordinator
Business Title : Clinical Data Management
Key Responsibilities :
 Serve as Data Operations Coordinator (DOC) for three global studies with
fewer than 5 operations staff
• Manage delivery of projects through full data management study life-cycle
(with minimal guidance).
• With guidance from DTL or Manager, manage project timelines and quality;
determine resource needs; identify out-of scope work.
• Serve as back-up for Data Team Lead (with guidance).
• Perform comprehensive data management tasks including data review,
writing and resolving data clarifications.
• Performdatabase designeractivitiesfortechnologies not requiring extensive
programming.
• Perform comprehensive quality control procedures.
• Independently bring project solutions to the CDMteam.
• Solve issues through using the global issue escalation/communication plan.

3. • Consult with Standards Group for process issues; communicate ideas for
process improvement.
• Assist in developing and implementing new technology.
• Understand and comply with core operating procedures and working
instructions.
• Meet objectives as assigned.
• InteractwithCDMteam memberstonegotiate timelinesand responsibilities.
Name of Employer : Quintiles technologies Pvt ltd, Bangalore
Date of Employment : From Oct 2011 to Apr 2014
Job Title : Clinical Data Coordinator
Business Title : Clinical Data Management
Key Responsibilities: • Serve as a Data Operations Coordinator (DOC) for multiple protocols
• Serve in the role of back-up to a Data Operations Coordinator
• Serve in the role of back-up to a Data Team Lead
• Conduct data review
• Over-viewing the projects for a particular client, escalating the issues and
providing resolution on study-related matters
• Conducting project-specific meetings with the sponsor and vendor on an
ongoing basis
• Write and resolve data clarifications
• Lead database audit team
• Develop and test databases and edit specifications.
• Understand and comply with core operating procedures and working
instructions
• Meet objectives as assigned
• Develop and maintain good communications and working relationships
with CDM team
Name of Employer : Quintiles technologies Pvt ltd, Bangalore
Date of Employment : Sep 2010 – Oct 2011
Job Title : Associate Clinical Data Coordinator
Business Title : Clinical Data Management
Key Responsibilities : Conduct basic data review, Write and Resolve data clarifications as directed
by the Data Operations Coordinator, Conduct basic quality control
procedures, Meet personal project objectives, as assigned by manager,
Escalate problems to the attention of the Data Operations Coordinator or
Group Manager, Understand and comply with core operating procedures and
working instructions, Understand, provide input to and comply with all
applicable sections of Data Management Plan, Understand basic database
structures, Develop and maintain good communications and working
relationships with CDM team.

4. Date of Employment : Sep 2009 – Sep 2010
Name of Employer : ICRC Kard Scientific labs, Cochin
Job Title : Clinical Research Trainee
Key Responsibilities : Assisted CRC In trial site
ACHIEVEMENTS
 As a DOC successfully locked an Inform study with 0% error
 Met 100% Individual quality every time
 Got reward from manager for mentoring the new joiners’ in an effective manner
WORK EXPERIENCE
 DB Lock of INFORM study as a Data Operations Coordinator (DOC)
 Start-up of INFORM and RAVE studies as a DOC
 Actively worked on locking activities of 4 Inform studies
 Handling ongoing RAVE and Inform studies as a DOC
DATA VALIDATION RESPONSIBILITIES (RAVE/INFORM PLATFORM):
1. As a DOC,executing the study as per the project plan and sponsor requirements.
2. To create a list of SOP’s specific to the project and ensure team members have documented and
posted in ELVIS.
3. To obtain and review budget, copy of contract, scope of work, signed protocol and client
specifications from the sponsor and provide to DOC.
4. To conduct and attend the internal project meetings, DM kick-off meeting, sponsor kick-off
meeting, pre-design meeting, online-screen review meeting
5. To create and review project plan, ALS, UAT requirements, eCRF design, draft edit specifications,
EDC cleaning plan, communication plan, data coding guidelines, data handling report, SAE
reconciliation guidelines, study data extract,core configuration and system settings.
6. Ensure UAT is completed for all the programmed and SAS/manual edit checks.
7. To design status reports and custom specific reports to the sponsor.
8. Discrepancy management and reconciliation of coding, SAE and non-ECRF data.
9. To ensure all the PRCF’s has been closed in a timely manner.
10. Ensure all the discrepancies are resolved and soft lock the eCRF forms once the casebooks are
signed by the PI.

5. 11. To sign the DB lock checklist and Hard lock of the database.
12. Archiving the study file for shipment to sponsor
13. Ensure quality of the database and delivering AdHOC works as per the sponsor’s needs
CLINICAL TRIAL EXPERIENCE
Phase Indication Role
Pilot study Oncology Data Operations Coordinator
Phase III Parkinson's Disease Data Operations Coordinator
Phase III Cystic Fibrosis Data Operations Coordinator
Phase I Bone Sarcoma Data Operations Coordinator
Phase II Cytomegalovirus Infection Clinical Data coordinator
Phase II Respiratory Tract Infection Clinical Data coordinator
Phase II Non-Small Cell Lung
Cancer
Clinical Data coordinator
Phase II Malignant Tumor of Kidney Clinical Data coordinator
Phase II Malignant Tumor of Colon Clinical Data coordinator
Phase II Malignant Melanoma Clinical Data coordinator
LICENSES AND CERTIFICATIONS
 Barnett GCP Accreditation, 2010
 Barnett Accreditation - Fundamentals GCP EXAM for support staff, on 24May2012
SOFTWARE SKILLS
 Operating Systems: Windows 2000/XP, MS-DOS
 Office Productivity: MS Office
PERSONAL STRENGTH
 Excellent initiator and problem solving abilities
 Ability to handle stress and conflict
 Able to work independently as well as in team environment
 Motivated with excellent time management skills
 Zealous and eager to learn new techniques
Data Management specific experience
Category Experience (in year)
InFormArchitect/Central Designer 4
MedidataRave 3.5
Managed StudyStart-Up 4
Managed Database Lock 3
DiscrepancyReview/QueryResolution 4
External Data Reconciliation 4

6. Category Experience (in year)
Database/EditCheckTesting 4
CONFERENCE PAPERS
 ‘Microbial Biofertilizers’ in the International conference on “Aquatic Microbiology”, University
of Kerala, Thiruvananthapuram.
 ‘Diagnosis of genetic disorder’ (Sickle Cell anemia) in the National symposium on Challenging
aspects in “Environmental & Molecular Biotechnology”, Pavendar Bharathidasan College of Arts
& Science, Trichy.
 “DNA bar coding” in the ‘One day intercollegiate microbes meet’, JJ College of Arts and
Science, Pudukottai.
 ‘Euphorbia hirta’ in the national level seminar on “Medical Plant Research & Marketing”,
Srimad Andavan Arts & Science College, Trichy.
EDUCATION
 Post Graduate Diploma In Clinical Research
IFCR, Cochin, Kerala, in association Sikkim Manipal University
 M.Sc., Microbiology- 76%
Srimad Andavan Arts and Science College: 2009
 B.Sc Microbiology – 70%
Srimad Andavan Arts and Science College: 2007
 Post Graduate Diploma in Computer Application - 91%
TNSPC: 2007
 Diploma in Medical Lab Technology - 55%
Apgar Institute of Paramedical Sciences, Trichy: 2006
PERSONAL DATA
Date of Birth : 13.05.1986
Sex : Female
Nationality : Indian
Languages : Tamil, English, Malayalam(R,W,S)
Hindi, Sanskrit(R, W)
DECLARATION
I confirm that the information provided by me is true to the best of my knowledge and belief.
I further add that I shall be able to join my duties at Two month’s notice, if appointed.
I assure you that I will prove myself a valuable person for this company.
I would be pleased to tell more about myself and my experience in person if I am called for an
interview.
Hope you would provide me with a spell to prove my competence.
Yours faithfully,
Place: Bangalore.
Date: 27Jul2015 R. BHAVANI