Krishna Kumar Menon Email & Phone Number

Tamil Nadu, India

Chennai, Tamil Nadu, India

Global SME for several process ( DTS, Specification Review and Creation, eSOURCE data Capture) and one of SME for Smart Data Query, worked on Cycle time reduction projects in Start Up and Conduct. Trained UAT team and vendor and oversight of the projects.

Chennai, Tamil Nadu, India

1) Set up of new UAT team and Operationally setting up Standard Process/ baselining Unit/managing vendor and resource management for deliverables2) Managing more than one trial as CDS Clinical Data Scientist by implementing Project Management Skills3) Involved in Smart Data Query (SDQ) project by providing input to machine for identifying queries4) Coaching DM team members on process and managing5) Involves in Continuous Process Improvement

Chennai Area, India

Data Operations Lead:1) Overall accountability for the execution of the Data Operations strategy and the Data Operations’ Technology set-up for the project’.2) Overall leadership / management for programming, data integration and data processing on a project / program.3) Liaising with project leadership, other functional leaders and the client as a single point of contact to ensure that the Data Operations deliverables with regard to timelines, quality, and productivity are… Show more Data Operations Lead:1) Overall accountability for the execution of the Data Operations strategy and the Data Operations’ Technology set-up for the project’.2) Overall leadership / management for programming, data integration and data processing on a project / program.3) Liaising with project leadership, other functional leaders and the client as a single point of contact to ensure that the Data Operations deliverables with regard to timelines, quality, and productivity are being met.4) Review (draft) protocol from a Data Operations perspective.5) Attend project kick-off meetings and lead Technical Kick-Off Meeting(s).6) Provide inputs on creation of eCRF, Data Validation Specification and monitoring the QC process in database development phase 7) Identify and request staff necessary for the project team.8) Be trained in client SOPs and disseminate knowledge to the Data Operation project teammembers.9) Provide input to project tools, project plan and providing training to Clinical Operations Representative on the Database Design.10) Creating DTS specification for External Data Transfer and confirming the transfers are completed appropriately.11) Providing access to all users on completion of training through UMT (User Management Tool).12) Submitting ticket for GO LIVE through Oracle Extranet and ensuring the study is LIVE.13) Effectively communicate with internal and external customers as well as third party vendors.14) Prioritize effectively and respond to urgent requests within team or from client.15) Participate in cross functional meetings and drive initiatives to ensure the delivery of milestones and timelines for clinical trials.16) Ensure information entered into internal management systems is accurate and updated on aregular basis17) Establish efficient / effective working relationships with other functional Leaders and experts Show less

Chennai Area, India

Manage timeline to bring issues captured, during UAT, to resolutionUAT Script Writing, Script Execution, QC test steps review addressing issue logsProvide regular written status reportMentoring Clinical Data Management professionalsQC test case Review and helped QC team in testing the databaseExtensive Knowledge in testing of INFORM 4.6/5.0......

Coimbatore Area, India

Prepared Data validation Plan Assisting in Edit check Program Implementation and assisting in database designCoordinating with the vendors Handling the teamUpdating the sponsor based on the timelinesTracking and receiving of Case Report Forms (CRF’s)CRF Designing and production with assistanceTo maintain Data management master File and log booksUpdate/correct/review data in the clinical databases based on resolved data queriesPerformed Data coding using standard… Show more Prepared Data validation Plan Assisting in Edit check Program Implementation and assisting in database designCoordinating with the vendors Handling the teamUpdating the sponsor based on the timelinesTracking and receiving of Case Report Forms (CRF’s)CRF Designing and production with assistanceTo maintain Data management master File and log booksUpdate/correct/review data in the clinical databases based on resolved data queriesPerformed Data coding using standard Dictionaries Coordinating with Clinical Research Associate to give high quality data InputTraining Clinical Data management professional to perform their activitiesFiling and archiving of study documentation, dispatching of queries to investigator sites for resolutionManaging the team and motivating the team members to achieve the deliverables on timeHaving experience in managing site, assisted team in file documentation and prepared Site Initiation Visit document Show less

B.Tech, Industrial Biotechnology

B.Tech, Biotechnology; 2007

Education record

EDUCATIONAL QUALIFICATION B.Tech (Biotechnology) Completed in 2007 with 81%at Shri Andal Alagar college of Engineering, Chennai affiliated.