ANITA KANAUJIA
Mumbai
Summary
A committed professional with a history of meeting company needs with consistent and organized practices and experience in Clinical Data activities. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand. Looking to take on a challenging role with an established organization.
Overview
8
8
years of professional experience
Work History
Senior Clinical Data Manager
Tata Consultancy Services Ltd. (TCSL)
Thane
09.2021 - Current
- Handled study from start-up, conduct to close out phase.
- Performed Mock eCRF testing & work closely with the study team and database developers to design a database that meets the study's data collection needs.
- Created edit checks for CRF data entry validation according to project specifications.
- Performed user acceptance testing on EDC systems and databases prior to study start-up.
- Reviewed case report forms for completeness, accuracy, consistency and adherence to protocol requirements.
- Resolved any discrepancies related to data collection or entry through effective communication with site personnel or sponsors.
- Performed Discrepancy Management, External data reconciliation, data listing review and other related tasks.
- Took part in meetings and committees to discuss Study timelines/ updates and communicate best ways to improve workflows.
- Ensured timely completion of database lock activities including analysis of queries generated by medical monitors or statisticians.
- Perform Pinnacle 21e Review.
- Performed a comprehensive final review of the study data to ensure accuracy and completeness for Database lock.
- Successfully managed multiple clinical trials, ensuring timely completion and accurate data collection.
- Mentored junior team members, fostering professional growth and enhancing overall team expertise in clinical data management functions.
Senior Lab Centralized Process Coordinator
IQVIA
Thane
08.2016 - 08.2021
- To do centralized monitoring of the day to day running of designated projects including all the responsibilities as detailed in project specific monitoring plan
- Liaising with other internal departments for all the appropriate process to be on scheduled
- Study set up phase- Upload details of the participating project sites in database, co-ordinate with couriers point of contact, to provide courier contact, pick up details etc
- To the participating sites and process initial kit shipment for the sites
- Conduct phase- Safety Report monitoring, conduct on going shipment, query resolution for smooth running of project and timely release of lab reports
- Close out phase- Completion of close out checklist, Monitoring close out (site close out as well) monitoring subject withdrawal of consent, Data Reconciliation
- Worked as an Internal Trainer to give initial training to the new joiners about the processes
- Mentoring Fellow colleagues (new Joiners) to familiarize them with the day-to-day activities carried out and help them until they are settled and when required
- SME (Subject Matter Expert) for one of the important activity - Query Management
- SME for LRMS (Laboratory Request Management System)
- Maintenance of study related data
- Experience of Working with LIMS system.
Education
PGDM in Healthcare Management -
Welingkar Institute of Management, NA
01.2020
M.Sc. -
S.I.E.S College, Mumbai University
01.2015
T.Y. B.Sc. -
V.E.S College, Mumbai University
01.2013
Skills
- Data Cleaning and Data Reconciliation
- User Acceptance Testing
- Data Validation Techniques
- Discrepancy management
- Medidata Rave
- Training and mentoring
- Effective Communication
- Interpersonal Skills
- Teamwork and Collaboration
Accomplishments
- Won several "Appreciation Awards" , "Bravo Awards" and "Employee of the Month" awards from different Sponsors/Study team and Managers for Quality work, customer Focus as well as Team work.
- Won at different inter-intra collegiate festival/event during Bachelors and Masters course
Activities
- Have managed the departmental "Fun-committee" team as the head of the group and organized many games for the team as stress-busters
- Volunteer in annual "Daan-Utsav" to celebrate the Joy of Giving week in my previous organization
- Active participation in different events held by the previous organization
- Organized as well participated in many inter-intra collegiate festival/events
Training
- Training on Clinical Microbiology in Grant Medical College and Sir J.J. Hospital, Sandhurst Road - Mumbai
- Medical Laboratory Techniques - As an Applied component in T.Y.B.Sc.
- Scientific Writing Course conducted by Department of Biotechnology of V.E.S College
Languages
Hindi
First Language
English
Proficient (C2)
C2
Marathi
Beginner
A1
Disclaimer
I here solemnly declare that all information furnished above is true to the best of my knowledge.
Timeline
Senior Clinical Data Manager
Tata Consultancy Services Ltd. (TCSL)
09.2021 - Current
Senior Lab Centralized Process Coordinator
IQVIA
08.2016 - 08.2021
PGDM in Healthcare Management -
Welingkar Institute of Management, NA
M.Sc. -
S.I.E.S College, Mumbai University
T.Y. B.Sc. -
V.E.S College, Mumbai University
Similar Profiles
Avinash GuptaAvinash Gupta
Business Process Lead at Tata Consultancy Services Ltd.(TCSL)Business Process Lead at Tata Consultancy Services Ltd.(TCSL)
MUKUL KHANDELWALMUKUL KHANDELWAL
Business Process Lead at Tata Consultancy Services Ltd. (TCSL)Business Process Lead at Tata Consultancy Services Ltd. (TCSL)
Suma Sree PorandlaSuma Sree Porandla
Assistant Software Engineer at TATA Consultancy Service Limited (TCSL)Assistant Software Engineer at TATA Consultancy Service Limited (TCSL)