Uma Vani Namani
Hyderabad
Summary
Analytical professional having experience working in contract research organizations, Specialized skills include project management and clinical data management in medical imaging. Excel in critical thinking, problem-solving, and communication, ensuring successful project outcomes. Results-oriented individual with a passion for continuous learning and innovation and deliver high-impact solutions in fast-paced environments who is looking for an opportunity to gain exposure and challenge my abilities to make a mark in the world of clinical trials
Overview
9
9
years of professional experience
Work History
Clinical Data Manager
Clario
Bangalore
09.2022 - Current
- Reviewed clinical protocols and developed data management plans to ensure accuracy of collected information for clinical trial databases
- Develop Data Management Plan (DMP) and design Database and Setup.
- Develop data capture, data validation plan, and draft the data transfer specifications and image transfer specification .
- Data transfer review, and Image transfer review and setup,
- Data reconciliation and Discrepancy Management, Charter review, and configuration review
- Receipt and processing of electronic data transfers like Interim and Final data transfers, Database locks, Study closeout.
- Handled internal and external Audits. Internal and External communications with the Programming team, validation team, science team, and IT team, etc.
Team Leader
Calyx.ai
Hyderabad
11.2019 - 08.2021
- Team Lead is responsible for coordinating the team effort of executing the technical and clinical data management functions required by the study protocol and providing support for project manager to facilitate study startup, completion and meet Quality and Timelines
- Assist with client communication related to general or customized project status and reports, Validate and maintain data base as required, Work and Provide directions to the project teams to work on data reconciliation and assigning cases to reviewers and assist them in determining appropriate action, Verifying e-CRF from source data, Result reporting, Result review and maintaining the clinical data, Executes technical and clinical functions as required by the study protocol in accordance to Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs), Held kick-off meeting to assemble project teams, assigned tasks, and delegated responsibilities, identified resources and reviewed detailed timelines, to ensure timely completion of assigned studies, Handle various reports such as enrollment report, Rave data, query, and subject summary reports, Responsible for communicating and identifying resourcing, training the need of special skill set and other study related requirements to the Line manager/ Project Manager, Responsible for communicating performance issues or identified gaps of project teams to their respective Line Manager, May provide feedback and evaluate content of Project Plan and start up activities to ensure appropriate documentation of all operational activities, Identifies issues and works with PM to determine best course of corrective action for resolving them, May assist in performing Site and project team trainings and quality checks if required.
Image Research Associate Level2
PAREXEL
Hyderabad
11.2018 - 10.2019
- Developed specialized documentation for projects
- Assisted in the development and orientation of new team members, ensuring smooth integration into the company culture.
- The rest of the responsibilities remain the same as IRA.
- Provide knowledge share sessions and perform second quality checks based on the necessity.
Image Research Associate
PAREXEL
Hyderabad
05.2016 - 10.2018
- Perform analysis and processing, data reconciliation of medical imaging data for clinical trials in compliance with study protocols and applicable regulatory agencies
- Issue and resolve queries with investigator sites and academic centers to ensure follow-up on imaging-related issues
- Perform image processing (including the downloading of imaging data from media, digitizing, data entry, region of interest measurements across multiple modalities (X-Ray, CT, MRI, PET, Bone scan, Photography) using Alice
- Good knowledge on utilization of image applications such as DICOM, DICOMWORKS, TOMOVISION, SANTE and also had work experience on Auto-export application (WIN-SCP)
- Experience on various tasks related to site management, Incoming and query group such as -Granting access to site personals for study, Querying and following up with sites to resolve site related issues, Escalating Quality issues and work closely with Team lead, Handling various project mailboxes, Data reconciliation, Identifying issues and bringing it to teams notice.
Billing E-support Officer
Knoah
Hyderabad
04.2015 - 03.2016
- Handling customer billing issues Via chat support for United states
- Proficiency in fair credit, debit practicing and accounting principles and collecting regulations
- Handle customer accounts, profiles and solve few technical issues regarding the customer accounts.
Education
Bachelor of Science - Bio-Medical Engineering
JB Institute of Technology
Hyderabad04.2014
Skills
- Project and clinical data management
- Data specifications and Data review
- Data reporting and reconciliation
- Team Management and resource allocation
- Exceptional verbal and written communicational skills
- Strategic planning and good at analytical skills
- Proficient in Microsoft applications
- Site and query management
- Knowledge on regulatory protocols (GCP & SOP) & also on medical devices
- Attended Audits and handled CAPA
Timeline
Clinical Data Manager
Clario
09.2022 - Current
Team Leader
Calyx.ai
11.2019 - 08.2021
Image Research Associate Level2
PAREXEL
11.2018 - 10.2019
Image Research Associate
PAREXEL
05.2016 - 10.2018
Billing E-support Officer
Knoah
04.2015 - 03.2016
Bachelor of Science - Bio-Medical Engineering
JB Institute of Technology
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