Gnyanada Venkatesh
Data Manager
Bangalore
Summary
Passionate clinical data manager with 7+yrs of experience working in fast-paced environments with diverse groups of individuals. Seeking to leverage my expertise in Clinical Data Management sector and work along with the challenging tasks, from which I can enhance my skills and potential to my best and exploit them to create new avenues in the interest of an organization and achieve excellence.
Overview
9
9
years of professional experience
Work History
Data Manager
Ergomed Clinical Research India Pvt Ltd
Bengaluru
10.2021 - Current
- Create and update project-related documents (e.g., Data Management plan (DMP), Data Validation Plan (DVP), Data Entry Guideline)
- Perform Screen/ DB UAT testing and validate edit checks
- Perform initial coding of verbatim entries on adverse events, medical history, and medications according to MedDRA and WHO-Drug dictionaries in clinical database and forward to medical expert for quality control
- Hands on experience with 3 EDC systems: Viedoc, OPVERDI, ZELTA [IBM]
- Generation of queries based on edit checks or errors and omissions identified during data entry and manual data review to resolve identified problems.
Data Manager
Ergomed Clinical Research India Pvt Ltd
Bengaluru
02.2017 - 07.2021
- Ensure electronic vendor data contains all protocol specific parameters, is in Correct format and data populate to specified fields and patients correctly
- Develop Data Transfer Agreement and Data transfer specifications for vendor data transfers and Lab addendum
- Review data discrepancies generated by study specific edit checks for external data and perform subsequent query management process in resolving data issues
- Responsible for drafting local lab and central lab edit checks
- Perform validation review of electronically transmitted data for a sample of total number of patients in study for loading purposes
- Communicate to vendors and client problems involving data transfers, data point issues and validation issues
- Attends and participates in required internal and external meetings and conference calls with sponsor
- Responsible for performing Monthly (or as applicable) reconciliation of lab data and highlighting discrepancies to vendor via issue log/site or CRA via queries in EDC
- Hands on experience with 3 EDC systems: Medidata Rave, Inform & Omnicomm Trial Master
- Perform lab eCRF review and locking of pages
- To make sure reference ranges are completely updated for all the local lab pages
- If not, find out reason and/or raise sticky notes to CRA
- Track progress of clinical studies, ensuring projects meets timelines and quality expectations
- When requested, assists with orienting, training, and mentoring newly hired Data Specialists
- And perform other duties as required by the Department.
Data Manager
Ergomed Clinical Research India Pvt Ltd
Bengaluru
12.2015 - 06.2016
- Profile refinement of the Scientists, Ph.D.
- Scholars, and researchers (related to cleaning of research papers and publications in their data base)
- Handling of QABO Tool.
Data Manager
Ergomed Clinical Research India Pvt Ltd
Bengaluru
12.2014 - 06.2015
- Handled Environmental Science subject for degree students.
Education
Skills
- Ability to work with and influence peers, project teams and management
- Excellent judgment and ability to interpret information
Self-directed, resourceful, highly motivated, energetic
Excellent organizational skills, ability to prioritize critical tasks
Good communication, good presentation, organization, and problem-solving skills
- Ability to multi-task and adhere to deadlines
- Mentor team members to encourage personal and professional growth
Therapeutic Experience
- Cardiovascular: Phase Ib
- Oncology - Phase I & Phase Ib
- Metabolic Disorders - Phase IIa
- Nephrology - Phase 1
- Respiratory - Phase I
- Diseases (Diabetic trails)- Phase 1, Type II diabetes mellitus (T2DM) with a clinical diagnosis of diabetic kidney disease (DKD)-phase 2a
- Musculoskeletal- Achondroplasia: Phase II
- Endocrinology and metabolism: Hypoparathyroidism: Phase II
Language Capabilities
- Kannada
- English
- Tamil
- Telugu
- Hindi
Awards
- Received ACE - Level 1 Award from senior management as a token of appreciation for the project that I was involved in- 2020
- Received ACE - Level 2 Award from senior management as a token of appreciation for the project that I was involved & successfully locking the study which had continuous timelines back to back in -2020
- Received ACE - Level 3 Award from senior management for successfully locking one of the critical studies & as a Client excellence in- 2019
- Received ACE - Level 3 Award from senior management as a token of appreciation for the project that I was involved in- 2019
- Received Star Award for responsibly handling individual projects as an intern in 2018
Disclaimer
I certify that the forgoing information is correct and complete to best of my knowledge and nothing has been concealed.
Timeline
Data Manager
Ergomed Clinical Research India Pvt Ltd
10.2021 - Current
Data Manager
Ergomed Clinical Research India Pvt Ltd
02.2017 - 07.2021
Data Manager
Ergomed Clinical Research India Pvt Ltd
12.2015 - 06.2016
Data Manager
Ergomed Clinical Research India Pvt Ltd
12.2014 - 06.2015
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