Jeny V

7 years of experience as a clinical coder & data manager in the pharmaceutical sectors. Adept at data validation, reconciliation, and EDC systems. I'm looking to use my experience to help clinical studies succeed and streamline data management procedures.

Associate Projects at Cognizant Technology Solutions (2017-01 – 2020-12)

• Perform accurate and consistent MedDRA and WHODrug coding by applying standard conventions, creating appropriate synonyms and managing coding-related queries as needed.
• Accountable for all coding related activities at program or therapeutic area levels may include direct interaction/stakeholders
• Utilized Medidata rave and Oracle inform to facilitate data capture, entry
• Reviews/provides feedback on coding performed by self or others to ensure consistency and quality.
• Trouble shoot the coding problems, collaborating with peers, database developers and/or IT support as needed
• Performed medical/clinical coding in accordance with departmental coding conventions and SOPs
• Interact and collaborate with clinical data management, drug safety, statistics to support in the process.
• Capturing, managing and reporting clinical research data in Phase I–IV studies (Protocol & Investigator coding by utilizing different coding systems) streamlining clinical trial process and helping life science organizations.
• Thorough knowledge of clinical trial methodology, clinical coding, medical terminology & also sound knowledge in protocol and investigator coding
• Excellent written communication skills, time management skills, ability to work well and flexibly
• Good team player, Maintaining Good relationship with team associates.

Clinical Coding Lead at GlaxoSmithKline (GCC) (2021-01 – 2025-12)

• Applying healthcare system knowledge to studies using real world data & Clinical trials
• Coding of medications & medical events, Review and resolve discrepancies identified by the system or through manual checks as per guidelines.
• Performing coding as requested by stakeholders responsible of each TA studies
• Extensive knowledge on multiple coding dictionaries such as MedDRA,WHODD, ICD10CM,CPT,ICD10PCS,NDC & SNOMED
• Performing data review using review reports to identify data issues like duplicate/fraudulent data entry, out of range lab values etc.
• Proactively work with asset team to identify clinical coding/data management needs for upcoming studies and provide expert consultation for study teams on the appropriate needs of given study and real world data set
• Maintaining Coding related sections of documents.
• Ensure that dictionary upgrades are completed in a timely manner across remit of trials
• Reviews/Provides feedback on coding performed by self
• Involve in the data collection, data validation, work closely with cross functional teams to support clinical data management of clinical trial data
• Completes tasks within timeframe by appropriately prioritizing multiple tasks within across projects and adapts to timeline
• Performs serious adverse events/adverse events reconciliation
• Ensuring adherence to available tools. Experience with Medidata rave, inform
• Ability to use sophisticated technical tool such as SQL, SAS
• Communicates effectively and precisely on regular coding activities, flags risks proactively and negotiates on reasonable timelines
• Assist manager with the selection, hiring, training development and performance management of staff within medical coding

Deputy clinical Manager at Veeda CR (2025-01 – Present)

• Perform coding (using MedDRA and WHO DD) accurately and efficiently
• Refer to the eCRF database for coding as necessary, ensuring that all the data are captured and coded accordingly to study protocols.
• Raise queries on internal platforms regarding coding, documenting all queries and resolutions for future reference
• Documentation of training materials for both internal/external stakeholders related to medical coding activities
• Prepare study coding reports to summarize coding activities and outcomes and any discrepancies during the coding processes
• Raise issues/queries with the study team summarizing any backlog or potential challenges related to coding during study
• involving in SAE reconciliation, Data validation, Data entry, Data review and resolve discrepancies identified by the system or through manual checks as per guidelines
• Coding of medications & medical events, Review and resolve discrepancies identified by the system or through manual checks as per guidelines.
• Performing coding as requested by stakeholders responsible of each TA studies
• Extensive knowledge on multiple coding dictionaries such as MedDRA,WHODD, ICD10CM,CPT,ICD10PCS,NDC & SNOMED
• Performing data review using review reports to identify data issues like duplicate/fraudulent data entry, out of range lab values etc.
• Proactively work with asset team to identify clinical coding/data management needs for upcoming studies and provide expert consultation for study teams on the appropriate needs of given study and real world data set
• Maintaining Coding related sections of documents.
• Ensure that dictionary upgrades are completed in a timely manner across remit of trials
• Reviews/Provides feedback on coding performed by self
• Involve in the data collection, data validation, work closely with cross functional teams to support clinical data management of clinical trial data
• Completes tasks within timeframe by appropriately prioritizing multiple tasks within across projects and adapts to timeline
• Performs serious adverse events/adverse events reconciliation
• Ensuring adherence to available tools. Experience with Medidata rave, inform
• Ability to use sophisticated technical tool such as SQL, SAS
• Communicates effectively and precisely on regular coding activities, flags risks proactively and negotiates on reasonable timelines
• Assist manager with the selection, hiring, training development and performance management of staff within medical coding
• Document all the coding decisions and rationales in a clear and concise manner to support transparency and facilitate future audits.
• Collaborate with clients to understand specifications for coding, ensuring that all the requirements are met and documented
• Work closely with the Data management and biostatistics team /clinical science team of the client
• Responsible for providing support, guidance and direction on all coding aspects to the CDM project team.
• Responsible for mentoring coding specialists as directed
• Trouble shoot coding related issues, technical and/or process related and provide support if required

M.Sc. in Biochemistry