Travelling
Deepanwita Dash
Clinical Data Management
Toronto,Ontario
Summary
PROFILE SUMMARY: Knowledgeable Clinical Data Manager bringing 6 years and thorough, hands-on approach to analysis and handling of data-retention systems. Successful in pinpointing and addressing complex information management flaws. Expert navigation of complex data storage, disposal and security guidelines to maintain compliance with confidentiality mandates. Critical qualitative analytical support and testing to resolve troublesome content access concerns.
Overview
6
6
years of professional experience
4
4
years of post-secondary education
1
1
Language
Work History
Sr. Clinical Data Coordinator
IQVIA RDS (India) Private Limited
Bangalore, Karnataka, India
12.2021 - 09.2022
- Acted as the lead data manager responsible for study-specific study start-up tasks, including case report form (CRF) design, edit check creation, CRF completion guideline (CCG) creation, and user acceptance testing including leading process improvements and enhancements, as needed.
- Have leaded data validation tasks for various studies during maintenance and close-out, focusing on data integrity and quality metrics.
- Have leaded the development and maintenance of the data management plan (DMP).
- Have leaded specific projects or tasks, during clinical trial conduct, ad-hoc report creation, maintenance of external data transfer documents, import/export agreements and data specifications, and support for database lock and archiving activities.
- Demonstrated strong organizational and time management skills while managing multiple projects.
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Managed time efficiently in order to complete all tasks within deadlines.
- Participated in team projects, demonstrating an ability to work collaboratively and effectively.
- Adaptable and proficient in learning new concepts quickly and efficiently.
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
- Acted as a team leader in group projects, delegating tasks and providing feedback.
Data Analyst
Cognizant Technologies Solutions
Kolkata, West Bengal, India
09.2019 - 10.2021
- Performing all data management related activity, issue tracking, quality review, testing, analysing and maintaining health of the study and timely update the health of study to Study team
- Liaising with the study team
- Effectively communicates progress and expectations around Data Science processes and the health of the study
- To perform, coordinate and ensure that discrepancy management activities are implemented following study data handling plans
- Ensures that global and study standards/conventions are followed
- Co-ordinate with assigned discrepancy management team to ensure data quality throughout the study duration
- Reviewing data particularly of edit checks that have fired and identifying trends followed by discussing with the clinical team
- Utilizing logic and reasoning to identify edit checks that are not working
- Communicating with other study team members as required e.g
- Clinical team lead, stats, safety
- Creating and updating of CRA Training slides, Data entry convention, Data management plan
- Identify errors and inconsistencies; resolve them or initiate their resolution to ensure high quality and timely database locks
- Maintenance of OMS (Operational Management System)
- Ensure study documentation is up to date throughout the study and submitted TMF/eTMF as appropriate
- Maintain documentation to ensure that documents reflect both the historical and current status of studies
- Conduct Trainings for new Associates and Act as Mentor for new joiners
- Participating process training, therapeutic training, activities, and knowledge sharing session
- Having the basic knowledge of implementing IDRP Checks in JARVIS
- Working on multiple database: RAVE, RAVEX, Edit check Engine, Spotfire, Jarvis, Trial manager, DS
- Hub, CDR Dashboard, VAULT, CITRIX
- Created various Excel documents to assist with pulling metrics data and presenting information to stakeholders for concise explanations of best placement for needed resources.
- Collaborated with business-unit leaders to identify and prioritize problems.
Data Manager
Cognizant Technologies Solutions
Kolkata, West Bengal, India
07.2016 - 04.2019
- Responsible for discrepancy management and data reconciliation across EDC
- Raise manual queries in the system and ensure timely closure with in TAT
- Working on Multiple databases: RAVE, RAVEX, LSH, CITRIX and SpotFire
- Ensure assigned studies achieve timely database lock
- Execute Data Management activities viz
- Data cleaning, Validating Manual & System Checks, and Update relevant trackers
- Working on various regular & ad hoc reports as per client requirements
- Ensure adherence to Cognizant and Client SOPs (Standard Operating Procedures)
- Responsible for performing external data reconciliation (PK,PD,PG)
- Utilize logic and reasoning to identify misfiring edit checks, which are not working and troubleshooting them and solve data related issues
- 100% compliance to timely completion of the client and cognizant required trainings.
- Reviewed source documents and listings to compile resources for identifying and correcting data allocation issues.
- Identified and resolved data-handling errors and hardware conflicts to maintain organizational IMS infrastructure.
Education
Bachelors of Pharmacy - Pharmaceutical Sciences
Biju Patnaik University of Technology (BPUT)
Odisha, India 08.2012 - 06.2016
Skills
Medidata Rave 564, Life Science Hub (LSH), Edit Check Engine (ECE), DS Hub, Trial manager, Spotundefined
Accomplishments
- Achieved 2 Study Hardlocks by completing various tasks with 100% accuracy and efficiency.
- Achieved Unicorn Award through effectively helping with critical tasks with my team members various studies.
- Achieved Time lines for 8 Interim Lock, 4 Snapshots with Data Cleaning.
Interests
Cooking
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
The way to get started is to quit talking and begin doing.
Walt Disney
Timeline
Sr. Clinical Data Coordinator
IQVIA RDS (India) Private Limited
12.2021 - 09.2022
Data Analyst
Cognizant Technologies Solutions
09.2019 - 10.2021
Data Manager
Cognizant Technologies Solutions
07.2016 - 04.2019
Bachelors of Pharmacy - Pharmaceutical Sciences
Biju Patnaik University of Technology (BPUT)
08.2012 - 06.2016
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