Srividya Shankarmanchi
Clinical Data Manager
Hyderabad
Summary
Seasoned Clinical Data Manager with 5.5+ years experience with End-to-End Clinical Data Management activities with effective communication skills aspiring to contribute my knowledge and experience in my prospect role/ organization.
Overview
7
7
years of professional experience
6
6
years of post-secondary education
Work History
Clinical Data Manager II
Parexel International Pvt Ltd
01.2023 - Current
- Work as Study Lead - Have been taking up the co- study lead role for study set-up phase in developing DVS, Offline Listings (DM, Medical, Offline Listing, Third party, CCI, IRT etc.); training the Team on DM activities as needed.
- Start-up activities - Involved in Development and Testing of Edit checks, Conditions and Dynamics for DVS; Independently handled Development and Testing of Offline Listings (Including Data Management, Medical, Protocol Deviations, External Vendors etc.) ; Testing of Protocol Deviations related Edit checks by working closely with the Study Lead and Data Management Lead
- Conduct and Lock activities - Independently Perform Vendor reconciliation Review and act as Point of Contact for the External vendor reconciliations; Perform Protocol Deviation review, Perform QC of tasks allocated to CDA's (Queries, Dataset review, Offline Listings review, Dataset review, Freezing and Locking etc.) and address the findings to maintain the quality of Database, conduct knowledge sharing sessions as and when needed to maintain the Team competency to meet the client requirement and deliver quality work on time.
- Working on the Tasks from Root - Thorough Understanding of Protocol, PDAP Plan, Data Transfer Agreements, Database design Specifications, Medical Data Review Plan and then accordingly work on the assigned tasks/activities
- Deliverables - Maintain the readiness to deliver for Interim Analysis, Dry run, IDMC, DB Lock etc : Involve in thorough review of the reconciliations on regular basis and follow up with Sites/Vendors on the outstanding issues to get them resolved if the issues do not get resolved through External Vendor trackers
- Optimal Effective Communication with Study Team as well as Manager - Maintain transparency in the study related activities both with the Study Team as well as Manager in order to maintain harmony in the team. I believe if the team is healthy, there will be effective productivity and effective delivery.
- Conducted ongoing assessments of data quality throughout the course of each trial, addressing any issues promptly and effectively
Clinical Data Manager I
Parexel International Pvt Ltd
07.2021 - 12.2022
- Conduct Activities - Independently perform Query Review, Offline Listing Review, Protocol Deviation Review, Medical Review, Third Party Reconciliations etc.
- Start up Tasks - Independently handled Development of Offline Listings and perform Testing of Edit checks, Dynamics, Conditions and Integrations
- Lock - Act as POC for Lock activities - DM Review and Freezing
- Maintain effective communication channel with the Study Teams
- Identify the gaps/ inconsistencies in Study Documents or EDC Database and notify the Study Team Lead: Identified the DVS Edit checks or Offline checks that are not in accordance with the Protocol/ suggested to add or delete the Edit check due to a logical reason that satisfies Protocol and other Study Documents/ Identify the programming issue in Offline Listings etc.
Associate Clinical Data Analyst
Parexel International Pvt Ltd.
10.2018 - 07.2021
- Lock Activities - Understand and Performed DM Review, Freezing and Lock activities
- Query Review - Understand and Perform EDC Query review, Offline Listing review, Protocol Deviation review, Vendor reconciliation review and Medical Review
- Effective Query writing in simple manner easily understood by site personnel
- Provide suggestions on Offline Listing Mockshell programming to get the exact dirt data in the listing output to get the issues easily resolved
- Take the Ownership of the Project activities and extend my support in various tasks when asked by the Study Lead
- Report the Project Status on Completed, Ongoing and Upcoming activities.
- Highlight the Outstanding issues from Site End/ Vendor end to get the issues resolved on timely manner
- Sensible to data related to Deliverables
Junior Research Analyst
Excelra
01.2017 - 10.2017
- Responsible for Excerption of Scientific data
- Responsible for reporting bugs associated with Data base
- Take part in Team discussion to improve quality and productivity of data excerption
- Report the ideas with regards to design of excerption tool whenever asked by Study Team
Education
M. Pharm - Medicinal Chemistry
Sarojini Naidu Vanita College of Pharmancy
Hyderabad 10.2015 - 12.2017
B. Pharmacy - Pharmaceutical Sciences
Vignan Institue of Pharmacy
Desmukhi 08.2011 - 08.2015
Skills
Accurate documentation
Discrepancy management
Understanding SOP's
Timeline
Clinical Data Manager II
Parexel International Pvt Ltd
01.2023 - Current
Clinical Data Manager I
Parexel International Pvt Ltd
07.2021 - 12.2022
Associate Clinical Data Analyst
Parexel International Pvt Ltd.
10.2018 - 07.2021
Junior Research Analyst
Excelra
01.2017 - 10.2017
M. Pharm - Medicinal Chemistry
Sarojini Naidu Vanita College of Pharmancy
10.2015 - 12.2017
B. Pharmacy - Pharmaceutical Sciences
Vignan Institue of Pharmacy
08.2011 - 08.2015