- Thanuja T has over 9 years of experience in clinical data management, primarily working in oncology. - She has worked at Quintiles as an Assistant Manager for the past 6 years managing clinical data and a team of 7 reports. - Prior to Quintiles, she worked at Accenture and Jubilant Biosys in data validation and research roles respectively.

1. THANUJA T
#27, Achappa block,
2nd
cross Dinnur,
R.T. Nagar,
BANGALORE- 560032.
Email: thanuja2006@gmail.com Ph No:+919886033874
SUMMARY:
• Having 9+ years’ experience majorly in clinical data management.
• Started career as Research Scientist at Jubilant Biosys Ltd from Aug 2005- Jul
2006
• Worked as Certified data validator in Accenture from Jul 2006- Aug 2008 in
Neuroscience therapeutic area in Accenture.
• Currently working in Quintiles as Assistant Manager.
• Have 6 years experience in Oncology and 4 years experience in project
management.
• Involved in end to end process in clinical data management.
• Worked in SDTM standards.
• People management experience of 1 year and currently handling 7 reports.
• Playing dual role of project management and people management.
• Good communications skills, team work and team management.
• Platforms worked: INFORM, RAVE, OC/RDC
• Involved in Rave post production changes and migrations
WORK EXPERIENCE:
SL.No Company Role Duration
1 Quintiles Pvt Ltd Assistant Manger Aug 2008- Till Date
2 Accenture Pvt Ltd Certified Data Validator Aug 2006- Aug 2008
3 Jubilant Biosys Pvt Ltd Research Scientist July 2005-Aug 2006

2. Role Wise Experience:
1. Assistant Manager- working from Oct 13-till date
• PLACE:QUINTILES
Role: Lead Data Manager:
Serve as primary point of contact for customer on data management
deliverables
• Provide project management expertise working with customer data managers,
key decision makers, and internal team members to manage continuous process
improvements, issue escalation, workload projections, and provide technical
expertise
• Provide justification for and perform direct negotiations with customer, e.g.,
timelines, financial, process, resources
• Maintain strong customer relationships
• Ensure open communications with customer and Quintiles management to
manage and meet contractual obligations
Service Management:
• Meet with Data Operations Coordinator (DOC) and/or Data Operations team
members on a regular basis to ensure milestones meet timelines and quality
deliverables
• Establish strong communications with Data Operations team, functional leads,
project managers and all other stake holders
• Support DM service delivery with comprehensive DM process and technical
expertise in executing projects
• Serve as the escalation point for unresolved data issues; work with client data
managers, vendors, internal team members for resolution
• Work with functional manager(s) to ensure appropriate resources are assigned
to meet project deliverables
• Create and/or review and sign-off on all data management plan (DMP)
documents
• Ensure service and quality meet agreed upon specifications per the DMP and
contract/SOW
• Implement proactive quality management plans across multiple
projects/program. Track service performance and provide leadership to identify
root causes of issues and implement remedial actions

3. • Continuously look for opportunities to improve service; work with team to
develop and implement plan to re-organize and drive change across multiple
projects/program (with minimal support)
•Ensure timely follow-up and resolution of compliance issues
•Serve as Subject Matter Expert (SME)
-Provide leadership and expertise in a specific CDM task or technology
•Train and mentor junior DTL staff in DM expertise. May coordinate the work of
more junior DTL staff
•Maintain internal tracking databases and systems
Financial Management/Business Development Support:
•Ensure service and quality meet agreed upon timelines and deliverables in
contract/Scope of Work (SOW)
•Manage SOW/budget-
Review financial reports on a monthly basis and participate in project reviews as
requested
-
Identify out of scope tasks and track change orders to completion
•Serve as Project Manager for single service DM projects, including financial
tracking, revenue recognition, and invoicing
Role: People Management:
People management for a team consisting 7 members
Guided the every team member of their career goal
Individual improvement and expectations depending their role and experience
was clearly explained to the team members
Constant team meetings and team outings were conducted.
Involved in individual ratings and performance bonus
2. Senior Clinical Data Coordinator- working from Oct10- Oct13
• PLACE:QUINTILES
• Serve as a Data Operations Coordinator (DOC) in leadership role in a specific
area of process on a Oncology studies.
• Conduct data review and training process for the team and groomed the team
the team
• Write and resolve data clarifications
• Lead database audit team
• Develop and test databases and edit specifications

4. • Understands and comply with core operation procedures and working
instructions
• Perform other duties and directed by the Functional Manager
• Meet objectives as assigned.
• Develop and maintain good communications and working relationships with
CDM team and the clients.
• Manage delivery of projects through full data management study life-cycle
(with minimal guidance).
• Manage project timelines and quality; determine resource needs; identify out-
of scope
work.
• Independently bring project solutions to the CDM team
• Solve issues through using the global issue escalation/communication plan.
• Consult with Standards Group for process issues; communicate ideas for
process improvement.
3. Clinical Data Coordinator working from Aug 08- Oct10
• PLACE:QUINTILES
Lead for 2 oncology studies as a Data operations Coordinator. Involved directly with
sponsor and other stakeholder to design and coordinate startup, conduct and DB lock
activities.
Working in the Clinical Research Organization. Exposed to end to end solution for the
data management and validation of the studies. Worked in the start up of the study.
Validated and worked on the checks and conditions required for the start up of the
study. Also, have experience on the conduct phase of the study that requires constant
follow up and current on data. Learned the local lab value checks and its relative
activities. Worked on back end checks and frontend checks. Worked on INFORM
platform and RAVE platform.
Some of the tasks I have excelled in:
• UAT of backend edit checks
• UAT of frontend data
• Ecrf frontend validation

5. • Discrepancy review and query management
• Lab review both local and central labs
• Handling medical queries
• Expert in protocol deviations and reporting of deviations
• Hands on experience on some of the paper based study review.
• Well-versed with various backend tools
• Worked on coding queries and sending appropriate feedback.
• Trained and mentored the new members of the team.
• I have been the single point of contact for the clients and the team members for
various updates in the study.
• Taken up tasks of team management and work allocation being the SPOC.
• Maintained a calm and good rapport with all the team mates that helped to face
the extreme pressure during database lock.
4. Worked as Certified data validation associate Accenture Pvt Ltd, from Jul
06 to Aug 08 (2 years)
• PLACE: ACCENTURE PVT LTD
Have handled 2 studies on clinical drug test on patients till database lock in therapeutic
area neuroscience. Got a clear-cut knowledge of the clinical trials and worked on it.
Have good knowledge about lab data and medical terms that are need to be standard
for the clinical database. Written guidelines and improvised on data cleaning through
various tools like Oracle database and OC.
5. Worked as Research Scientist at Jubilant Biosys Ltd, since August 2005 in
PathArt project from Aug 05 to Jul 06(11 months)
• PLACE : JUBILANT BIOSYS LTD
PROJECT: PathArt

6. PathArt is a comprehensive collection of manually curate data on more than 1000
signaling and metabolic pathways taken from literature as well as public domain
databases. I have worked on diseased pathways like Stomach Cancer and physiological
pathways like Thrombopoiesis, Myogenesis, Monopoiesis, Neurogenesis, where I was
involved in data mining, annotation and curation of the pathways and application of
skills in database creation. My expertise lies in identification disease pathways and the
critical disease genes, pathway crosstalk, comparison of pathways across physiologies,
diseases, and organisms.
Education Qualification
M.Sc Biochemistry from Bangalore University: 2003-2005
B.Sc Biochemistry, Genetics from Bangalore University: 2000-2003
Seminars and Symposiums:
Presented on the following topics:
 Diabetes Mellitus: an overall summary of biochemical changes in body during
Diabetes and brief note on causes, diagnosis, effects and cure to the disease.
 Amphipathic Peptides and Drug Delivery: a review article on cell penetrating
amphipathic peptides having a wide application in gene therapy and drug
delivery. This article is based on the principle that hydrophobic and hydrophilic
residues of the peptides interact with the plasma membrane facilitating the
peptide delivery.
 Novel Monoclonal Antibodies Demonstrate Biochemical Variation OF Brain
Parkin with Age: a research article dealing with the production of antibodies for
protein called ‘Parkin’ which modified in Parkinson’s disease.
 Presented overview and data management review for the study project I worked
in Quintiles.
Attended:
 “Bioneers” a three day symposium conducted by Jain Group Of Institution
 Seminar on Auto- antibodies by Dr Srinivas Kaveri, Pasteur Institute.

7.  Seminar on polyviral disease by Dr H.S Savitri, Professor of Department of
Biochemistry IISC.
Project:
Undergone training in EROS PHARMA LTD in the areas of Quality Control of
Pharmaceuticals with a focus on HPLC methods of analysis for 15 days.
This project has given an exposure to handle instruments like FTIR, Polarimeter,
K.F titremeter, and spectrophotometer, HPLC.
References:
Available upon request.