Varsha Singh
Protocol Data Manager
Bengaluru
Summary
one Profile Clinical Data management professional with over 8 years’ experience in end-to-end Clinical Data Management (early & late-stage studies), EDC, Project management & Client Management. Worked extensively in Oncology, Hem-oncology and Immunology studies.
Overview
8
8
years of professional experience
5
5
years of post-secondary education
Work History
Support Manager
- Team development (training, mentoring)
Protocol Data Manager
Accenture
Bangalore
04.2021 - Current
- Perform end-to-end Data Management activities across multiple trials as lead
- Lead and participate in trial start up activities including study kick off meeting, Protocol review, eCRF design review, online screen review meetings
- Provide inputs to Sponsor and study team on review, edit check specifications, Co-ordinate with programming, technical designing, validation team and other stake holders to achieve milestones and deliverable according to the project plan
- Perform and monitor study conduct activities including External Data Reconciliation, Query clinical Sites on discrepancies, Performing SAE reconciliation, SDTM Reconciliation, lab data review etc
- Manage customer relationship for DM project team including active participation in DM customer negotiation on timelines, scope of work, project risk identification & mitigation plan creation
- Manage project timelines, quality issues, determine resource needs, and identify and justify out of scope work
- Prepare monthly plan for resource allocation to perform the study related activities
- Coach, train team members to the next level through classroom training
- Ensure all quality activities are performed and findings are addressed
- Collaborate with all the other study stake holders to understand the protocol, study requirements and timelines
- Responsible for preparing the eCRF Completion Guidelines (CCGs), Data Management plan Protocol Deviation, performing QC for User Acceptance Testing (UAT)
- Preparing for Interim Database locks, audit readiness, external data reconciliation and SAE reconciliation, final Database lock activities etc
- Manage project timelines and Track changes to the initial project plan ensure approved changes are implemented
- Maintain and update the study documents in the study folder as per the standard procedures and client requirement
- Sharing weekly status reports to external clients and other stakeholders
- Review, update and Train sites, investigators on using new updates to EDC system and data trends for studies
- Conduct study closeout activities including Final data cleaning activities as DB lock checklist, locking &
- Freezing of eCRF’s, getting all the sign off’ s for DB lock
- Responsible for utilization of staff
- Assessing and documenting competency of staff to satisfy position responsibilities
- Participate in performance reviews of team members.
Clinical Data Reviewer
Accenture
Bangalore
03.2020 - 03.2021
- Run Clinical data listings and review accordingly
- Identify potential protocol deviations and raise required queries to site
- Perform Oncology specific listings review
- Perform SAE Reconciliation review
- Highlight the data related issues to the PDM when required
- Assist Lead in tracking and monitoring the progress of CDR data activities.
Clinical Data Manager
Accenture
Bangalore
01.2019 - 02.2020
- Perform listing review, cleaning, and consistency checks as specified in the PDRP
- Work on Ad hoc tasks as and when required
- Perform page inactivation as and when required
- Highlight the data related issues to the PDM when required.
Clinical Data Specialist
IQVIA
Bangalore
09.2017 - 09.2019
- Perform Start up, Conduct and Closeout data review activities
- Understand and comply with core operating procedure and work instructions
- Understand, provide input to, and comply with all applicable sections of Data management Plan document
- Share weekly status reports to external clients and other stakeholders
- Oversee all the data management activities within the team
- Highlight the data related issues at the correct time
- Resolving the data issues within the team
- Mentor new joiners
- Communicate directly with LDM and other stake holders
- Lead a small team of associates and guide them on approaches and methodologies and project execution.
Clinical Data Associate
IQVIA
Bangalore
07.2015 - 08.2017
- Perform tasks like Query Management, SAE Reconciliation, Important Protocol Deviations review, External data reconciliation
- Perform Final data cleaning activities as per DB Lock checklist
- Perform Biostatistical listings, and SAS listings review.
Education
M.Sc. - Biotechnology
AMC College, under Bangalore University
01.2011 - 04.2013
B.Sc. - Biotechnology
Zakir Hussain Institute under Sikkim Manipal University
01.2009 - 04.2011
Skills
Leadership, Customer Service, Strong Communication Skills,Project Management, Active Listening
undefinedTimeline
Protocol Data Manager
Accenture
04.2021 - Current
Clinical Data Reviewer
Accenture
03.2020 - 03.2021
Clinical Data Manager
Accenture
01.2019 - 02.2020
Clinical Data Specialist
IQVIA
09.2017 - 09.2019
Clinical Data Associate
IQVIA
07.2015 - 08.2017
M.Sc. - Biotechnology
AMC College, under Bangalore University
01.2011 - 04.2013
B.Sc. - Biotechnology
Zakir Hussain Institute under Sikkim Manipal University
01.2009 - 04.2011
Support Manager
Similar Profiles
KOMAL MOREKOMAL MORE
Professional Development | May 2025 – Present at NAProfessional Development | May 2025 – Present at NA
Shlomo JaffeShlomo Jaffe
Highschool Math Tutor at NAHighschool Math Tutor at NA
Tenzin Lhaki DorjiTenzin Lhaki Dorji
English Tutor at NAEnglish Tutor at NA
Madeline CookMadeline Cook
Babysitter at NABabysitter at NA
PARTHIV RAJAGOPALPARTHIV RAJAGOPAL
Associate System Engineer at THOMSON REUTERSAssociate System Engineer at THOMSON REUTERS