Objective

Highly motivated professional interested in attaining a challenging position in the field of Clinical Research which
enables me to show my capabilities, skills and proficiency with a reputed organization and help in improving quality of
medicine research through efficient and effective data management processes.


Professional Experience Summary
As Manager I have a team of Data Managers working under me.
As an Clinical and Lead Data Manager I am the first point of contact for the Clinical Trial Team (CTT) in relation
to all data management deliverables starting from start up to database lock, issues and questions from trial
teams and responsible for resolutions for the same.
I have worked in different therapeutic areas like Respiratory, cardiovascular and metabolic disorders and
Oncology.
Good experience in handling many CRO studies for which Data Management deliverables are outsourced.
Ensure adherence to applicable SOPs
Perform /assist with trial set up activities, as required ensuring accuracy consistency and standardization within
a project/therapeutic area.
Coordinate and collaborate with the Trial Data Managers (TDMs) and/or Data Managers (DMs), Project Leads,
Statisticians, programmers, Standards committee team and CRAs to track and report status and progress of
data management deliverables (like Database lock, DMCs and IAs) for allocated trials.
Create / Review and provide inputs to all Trial specific documents like edit check documents, Mock CRF
creations, Data handling and CRF Completion guidelines etc.
I actively participate in Protocol review meetings with Clinical to ensure DM components are as per
expectations and to identify new standards if any.
Support database review, testing and UAT of edit checks specifications and study design for assigned studies.
Ensure audit readiness and participate as required
Ensure sharing of learning across geographies
Manage relationships with Clinical Trial Teams at both the operations level and with functional peers
Actively Participate in Study Kick Off meetings and Clinical Trial Team meetings for the assigned trials ensuring
appropriate level of support and communication provided.
Timely issue escalation and responsible for CAPA definition and implementation for assigned trials, in case of
audit findings, if any.
Provide data management training to external vendors and investigators sites like IM meeting presentation
whenever required.
Experienced in Third party reconciliations, creation and review of Third party Data Transfer specifications, SAE
Reconciliation, Adjudication and Protocol deviation management.
Responsible for tracking the various data management activities using study reports/metrics- as applicable
Prepare Service Order for Trial budget-as applicable
Worked on different platforms like Novartis EDC and OC RDC.
I have experience in co-ordination of trainings as a training coordinator in Cognizant and I was an active
member for client negotiations, face to face meetings, audit readiness, handling and resolving process
escalations.


Experience
Total Experience: Ten years
1. Data Management: Seven and half years
2. Others: Three years

Manager (Oct 2013 till date)
Company: Tata Consultancy Services, Mumbai.

Clinical Data Specialist to Clinical and Lead Data Manager (Apr 2009 till Sep 2013)
Company: Novartis Healthcare Pvt. Ltd., Hyderabad.

Clinical Data Analyst (May 2006 till Mar 2009)
Company: Cognizant Technology Solutions, Mumbai.

Production Chemist Liquid Orals (Jun 2003 till Apr 2006)
Company: Indoco Remedies and Pharmax Pvt. Ltd, Mumbai

Trainings: One month Industrial training at Kilitch India Pvt. Ltd., Navi Mumbai.


Education:
Degree Institute/University Year of
passing
Grade
Diploma in Clinical Research K.M. Kundnani College of Pharmacy June 2006 First Class
Bachelor of Pharmacy Bombay College of Pharmacy (Mumbai
University)
June 2003 First Class
Diploma in Pharmacy NSS College of Pharmacy (Maharashtra
Board)
May2000 Distinction
HSC S.I.E.S College of Pharmacy (Maharashtra
Board)
Mar 1998 First Class
SSC Our Lady of Fatima High School (Maharashtra
Board)
Mar 1996 First Class


Achievements
I am part of process development team, received accolades and appreciations for timely, quality and efficient
handling of deliverables.
Have developed process related trainings to enhance the data management process.
Have been nominated for Team and Personal building workshops as an achievement for excellent performance.
Awarded Scholarship from Sir Ratan Tata Trust for completing Pharmacy with distinction

Special skills/Competencies
GCP and regulatory guidelines awareness
Excellent written and oral communications and presentation skills
Teamwork and cooperation
Concern for quality and attention to detail, analytical thinking, customer focus