Data Management Clinical

DEEPANWITA DASH

Toronto, Ontario M*P *C* • +1-905-***-****

****************@*****.***

SUMMARY OF QUALIFICATIONS

• Have 6 years of experience in the field of Clinical Data Management for Phase I-III studies including Start Up, Conduct and Closeout activities.

• Well versed in Oncology, Immunology and Gen-Med Therapeutic area.

• Strong background in Query Management, Data Management and Edit Checks.

• Sound knowledge in SAE Reconciliation, Vendor Data Reconciliation and ePRO Reconciliation.

• Ability to Lead study-specific study start-up tasks, including CRF design, EDC, CRF completion guideline creation, and User Acceptance Testing including process improvements and enhancements.

• Am quite adaptable and proficient in learning new concepts quickly and efficiently. AREAS OF EXPERTISE

Medidata Rave 5.6.4 Life Science Hub (LSH)

Edit Check Engine (ECE) DS Hub

Trial Master File (TMF) Spot Fire

Citrix Vault

PROFESSIONAL EXPERIENCE

IQVIA RDS (India) Private Limited, Bangalore, India Senior Clinical Data Manager 2021 – 2022

• As a Lead Data Manager have coordinated various studies during maintenance and close-out, focusing on data integrity and quality metrics.

• Have strong Organizational and Time Management skills while managingmultipleprojects.

• Have leaded the development and maintenance of the Data Management Plan (DMP).

• Have leaded and supported, Clinical Trial Conduct, ad-hoc report creation, maintenance of external data transfer documents, import/export agreements and data specifications, database lock and archiving activities.

• Have prepared Health of Study (HOS) slide and presented before sponsors.

• Organized and participated in Team building, Collaboration Activities and Kick-Off meetings with Study team before Go-Live.

• Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.

• Acted as a Study POC for multiple studies, assigning tasks and provided continuous feedback.

• Have ensured smooth Knowledge transition to new joiners and took care of their study related Access using Service Now.

Cognizant Technology Solutions, Kolkata, India

Clinical Data Analyst 2019 – 2021

• Performed all data management related activity such as issue tracking, quality review, testing, analyzing, and maintaining health of the study and timely update the health of study to the Study team.

• Reviewed Manual queries, identified errors and inconsistencies in real time basis to ensure smooth data cleaning.

DEEPANWITA DASH

Toronto, Ontario M4P 0C6 • +1-905-***-****

****************@*****.***

• Performed, coordinated, and ensured that discrepancy management activities are implemented following study data handling plans.

• Ensured that global and study standards/conventions are followed.

• Co-ordinated with assigned discrepancy management team to ensure dataquality throughout the study duration.

• Reviewed data, particularly of edit checks that have fired and identifying trends followedby discussing with the clinical team.

Clinical Data Manager 2016 - 2019

• Performed discrepancy management and data reconciliation across EDC (RAVE, RAVEX). Also worked on LSH, CTRIX and Spot Fire.

• Raised manual queries in the EDC system and ensured timely closure.

• Involved in database lock activities such as Interim Lock, Soft Lock and Hard Lock.

• Worked on various regular & ad-hoc reports as per client requirements.

• Ensured adherence Client SOPs (Standard Operating Procedures).

• Performed external data reconciliation such as PharmacoKinetic-PharmacoDynamic and PharmacoGenetic).

• Utilized logic and reasoning to identify misfiring edit checks, which were not working and troubleshooting them and solve data related issues. EDUCATION

Bachelor of Pharmacy 2012 - 2016

Biju Patnaik University of Technology (BPUT) - Odisha India

For any interview schedule, please kindly send an email to ****************@*****.*** to book a time instead of calling directly, thank you so much for your cooperation.

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