Ambeka Dinesh Kumar Email & Phone Number

Bengaluru, Ka, In

Bengaluru, Karnataka, India

Study status tracking, Data entry and VerificationIdentification of data issuesData cleaning and query raisingDatabase update as per query response Study close-out activities like reconciliation activities etc as assignedArchiving of all study related documentsParticipate in appropriate project meetingsResponsible for providing feedback on performance of team members to Line Managers in CDM as appropriate

Bengaluru Area, India

Collaborate with project teams with primary responsibility for review of the clinical database for quality and accuracy to support the delivery of clinical data according to client quality and integrity specifications, according to project guidelines.Develop Quality Management (QM) Plans for assigned projects.Train new QM personnel as well as project specific quality reviewers. Participate in client audits for assigned studies and potential to participate in client capability… Show more Collaborate with project teams with primary responsibility for review of the clinical database for quality and accuracy to support the delivery of clinical data according to client quality and integrity specifications, according to project guidelines.Develop Quality Management (QM) Plans for assigned projects.Train new QM personnel as well as project specific quality reviewers. Participate in client audits for assigned studies and potential to participate in client capability audits.Potential to develop QM Training presentations.Assist Data Management in maintaining the studies in an audit ready condition through appropriate Quality review activities.Potential to assist in proposal process regarding QM costs/hours. Show less

Bengaluru Area, India

• Work concurrently on multiple data management projects, and with little to no guidance from functional manager/PDM • Provide input and assistance in the design of Case Report Forms (CRFs). • Able to assist study specific edit check specifications • Assist in reviewing/writing/editing sections of the Data Management Plan and eCRF Completion Guidelines at the direction of the Project Data Manager • Perform necessary interpretations of compare output and provide feedback to DM… Show more • Work concurrently on multiple data management projects, and with little to no guidance from functional manager/PDM • Provide input and assistance in the design of Case Report Forms (CRFs). • Able to assist study specific edit check specifications • Assist in reviewing/writing/editing sections of the Data Management Plan and eCRF Completion Guidelines at the direction of the Project Data Manager • Perform necessary interpretations of compare output and provide feedback to DM Project Leader for resolution and database edits in DM • Reconcile project files, reports, listings and other documents generated in data management against a database for accuracy and completeness of data management processes. Assist with provision of data management reports in support for project team, Clinical Research Associates (CRAs), investigative sites, sponsor as requested. • Demonstrate/describe data review processes to sponsors and auditors as and when needed • Perform all tasks to relevant Chiltern and/or Sponsor SOPs, ICH or other regulatory guidelines in DM • Work in a timely manner in accordance with all the activities specified in the agreed project budget, under the supervision and guidance of the Manager/ Project Data Manager • Provide guidance and training to Level 1 and 2 CDA colleagues as well as new hires • Perform other duties as required by the Department Show less

Bengaluru Area, India

Work concurrently on multiple data management projects, with minimal guidance from line manager or experienced colleagues.2. Support User Acceptance Testing (UAT) for validation (edit) programs as requested. Test data entry screens per data entry guidelines and Case Report Forms (CRFs) for selected projects3. Assist in reviewing/writing/editing sections of the Data Management Plan and eCRF Completion Guidelines at the direction of the Project Data Manager4. Independently perform… Show more Work concurrently on multiple data management projects, with minimal guidance from line manager or experienced colleagues.2. Support User Acceptance Testing (UAT) for validation (edit) programs as requested. Test data entry screens per data entry guidelines and Case Report Forms (CRFs) for selected projects3. Assist in reviewing/writing/editing sections of the Data Management Plan and eCRF Completion Guidelines at the direction of the Project Data Manager4. Independently perform additional data cleaning tasks which includes logic checks using listings and reports as needed, SAE reconciliation, and identification of issues and data trends, EDC dataset QC, perform interpretations of compare output and provide feedback to Project Data Manager for resolution and database edits5. Generate data complex data queries as directed by Manager/Project Data Manager with minimal guidance required from respective personnel6. Conduct quality control processes including CRFs to database review7. Reconcile project files, reports, listings and other documents generated in data management against a database for accuracy and completeness of data management processes8. Provide guidance and training to Level 1 and new hires into the CDA role9. Perform all tasks to relevant Chiltern and/or Sponsor SOPs, ICH or other regulatory guidelines in Data Management10. Perform other duties as required by the Department Show less

Bangalore

• Curating measures using Analytic engine.• Locating the specification for the healthcare quality measure to implement. • Interpreting the healthcare quality measure specification. • Identifying the measure’s data criteria. • Breaking down data criteria into standard rules and measure-specific parameters to pass to the rules. • Requesting that the SQL Developer create the SQL code for a rule that the measure’s data criteria requires but that does not yet… Show more • Curating measures using Analytic engine.• Locating the specification for the healthcare quality measure to implement. • Interpreting the healthcare quality measure specification. • Identifying the measure’s data criteria. • Breaking down data criteria into standard rules and measure-specific parameters to pass to the rules. • Requesting that the SQL Developer create the SQL code for a rule that the measure’s data criteria requires but that does not yet exist. • Joining a measure’s data criteria by mathematical and logical operators • Assigning healthcare standard codes and/or code sets to rules. The Analytic Engine uses the codes when evaluating performance data for the associated functional measure. Show less

Bengaluru Area, India

Bengaluru Area, India

Served as a DOC, SAE reconciliation, IPD reconciliation, Manual review, SAS Review, Query management

• Performed data management tasks including discrepancy review, query generation.• Performed manual and Electronic reviews on data.• Have assisted DOC activities and also served as a DOC representing CDM on the project team.• Test database and edit specifications.• Review discrepancies and send queries to Investigator sites.• Assist in the review of study specific listings and tables (I review).• Update the clinical database in a methodical, logical manner.• Resolves… Show more • Performed data management tasks including discrepancy review, query generation.• Performed manual and Electronic reviews on data.• Have assisted DOC activities and also served as a DOC representing CDM on the project team.• Test database and edit specifications.• Review discrepancies and send queries to Investigator sites.• Assist in the review of study specific listings and tables (I review).• Update the clinical database in a methodical, logical manner.• Resolves routine data related questions.• Understanding and complying with core operating procedures and working instructions.• Performed basic quality control procedures.• Worked in studies related to different types of cancer and bone disorders. Show less

DOC) for five protocols with less then 5 operations staff.Collaborated with other study team members to monitor study progress and resolve issues at the site level.Communicated data related issues to team members to ensure that data management activities are in compliance with study timelines, ICH-GCP guidelines, Quintiles SOPs and local regulatory guidelines or regulations.All projects handled were Early Development projects with indications of Asthma, SLE… Show more DOC) for five protocols with less then 5 operations staff.Collaborated with other study team members to monitor study progress and resolve issues at the site level.Communicated data related issues to team members to ensure that data management activities are in compliance with study timelines, ICH-GCP guidelines, Quintiles SOPs and local regulatory guidelines or regulations.All projects handled were Early Development projects with indications of Asthma, SLE, Hypercholestermia,SchizophreniaWorked on Medidata RAVE database.Served as a back up DOC.Write and resolve data clarifications.Met objectives as assigned.Performed UAT testings for RAVE database.Supported training of project team on project specific and data management processes.Performed reconciliation of SAEs.Liaised through the Data team leader with monitor, database programming, medical coding and statistical programming teams to ensure smooth functioning of studies.Shared experiences and best practices through coaching and feedback. Show less

M.Sc, Biotechnology

Masters, Biotechnology

Bachelors and Masters in Biotechnology

Bachelors, Biotechnology

Pre University, Science

Icse

Icse

Education record