Abhijith Cr Email and Phone Number

AI/ ML Products, CDM Automation, AI Clinical Analytics, Projects + People ManagementAI/ ML Products, CDM Automation, AI Clinical Analytics, Projects + People ManagementSkills: Clinical Data Management · SME for AI/ML products, CDM automation, clinical data management, data analytics, · SME for AI/ML products used in clinical trials

• Review protocol and query preparation on protocol• Develop specifications, create database, test database, program edit checks, prepare test data for edit check specification, test edit checks and annotate SDTM CRF• Utilize primary development tools such as but not limited to Medidata Rave, Open Clinica, Medrio, SAS and other supporting tools. While under the guide of a lead clinical programmer, use the applicable tool to program, validate, and maintain databases to meet specifications in a timely and productive manner following SOPs • Serve on project teams to support clinical programming activities for projects. Attend meetings, participate in discussions, use an analytical approach to problem solving, and focus on deliverables. Consistently achieve assigned timelines that impact project target dates. Escalate potential problems effectively and in a timely manner. Balance multiple task assignments and communicate needs to supervisor to obtain needed resources• Generate, maintain and archive all study related documents• Perform database QC activities• Collaborate with clients, peers, lead programmers, project teams, and/or requestors to clarify specifications and use expanded technical skills to meet evolving project needs• Actively contribute/participate in departmental review meetings• Possess and maintain a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, professional meetings, etc• Assist in audits• Effective time management in order to meet daily metrics or team objectives• Independently perform all clinical data cleaning activities on assigned projects• Study close-out activities like reconciliation activities• Render CSR word file to PDF, create bookmarks and hyperlinks • Perform quality control (QC) checks on electronic submission documents to meet FDA and client specifications

• Study Initiation Activities.• Study status tracking.• Keep on tracking of all updated study related documents and mails • Assigning study specific tasks to study team personnel • Train team members on selected tasks• CRF/Database Designing.• Perform User Acceptance Testing.• Edit Check SpecificationPreparation/Review/Programming /Testing • Perform Database deployment checklist before deployment • Deliver the Study specific documents as per the timeline to the Team Lead.• Update Database based on protocol amendment.• Participate in appropriate project meetings.• Other duties assigned by immediate supervisor/manager