Arun Kumar S

Product development:

• Collecting, analyzing and preparation of detailed of Business Requirement Specification (BRS)
• Detailing Software Requirement Specification (SRS) including Use case review and approval
• Functional review discussion, Q&A with product development team
• Requirements detailing to development and testing team
• Unit and System test case review and approval
• Owning product backlog – Periodic review and update
• Validation summary report review and approval
• Perform competitor analysis
• Need to suggest for new features based on current market requirements

BD and Sales:

• Managing third party infrastructure for lead generation through cold call
• Imparting product training to third party for lead development
• Participating in clinical trial conferences like SCDM, DIA and Clinical trial Summit – Representation from the stall and product detailing
• Providing detailed product demo to prospective clients
• Provide and manage sand box environment for prospective clients
• Maintain and follow up pipeline leads
• Working on RFP/SOW
• Handling client negotiation and internal pricing approval

Client deliverables:

• Imparting extensive in-person product training at client place covering all the modules
• Functionality clarification and support during eCRF development, edit check specifications, Data review & cleaning, Discrepancy management and Medical coding
• Understanding the client specific or project specific requirements and give input to the development team for deliverables

Inter Department accountabilities:

• Involvement in client audits including product presentation to auditor
• Provide domain training to all the development and training team
• Working with marketing team for product brochure and other manual
• Review and approve user manual and product help files
• Vendor management for software development (eLearning), UMC – for Coding developer license etc
• Work with Accounts receivables for periodic client billing based on the clinical trial progress.

• Handling the trial individually as a Trial Data Manager
• Managing the team related to work distribution and meeting the timelines
• Involving in study start up activities
• Ensure quality control of deliverables
• Participation within the clinical trial team – Discussion, meeting for the complete data review and cleaning process
• Performing SAE reconciliation (Safety data review between Clinical and Argus Database)
• Performing complete Discrepancy management and all third-party reconciliation
• Taking care of manual and auto upload Protocol Deviations and Database lock activities.

• Protocol review
• Paper/eCRF development
• Generating Data management plan (DMP) generation
• Tracking of DCF and generating query to the trial site
• Updating the database with query resolution and SDCF from site
• Performing 100% QC on all safety and efficacy parameters
• Distributing the work and study documentation as per SOPs
• Ensure provision of timely, efficient, high quality Data Management deliverable for clinical projects and trials within the Group.

• To coordinate the quality checks of records to meet out the required specifications and standards before delivering to the client
• Receiving articles, CODEN separation, diskette allotment and distribution, excerption tracking, receiving soft copies, redistribution to quality team, correction, editing, proof reading and final delivery
• To meet the Productivity and Quality of monthly and yearly targets
• Client Interaction:
• Communicate with the client for project requirements, technical queries, targets, business and delivery plans
• Training and People Management:
• Training new excerptor for the BEILSTEIN database curation
• Conducting seminars, workshops, group discussions, presentations and brain storming sessions in the team for regular updation of the rules in curation
• Approving leaves of the associate
• Performing annual performance appraisal for the team members.

• Bio curation of articles related mainly to Clinical and Experimental Pharmacology, Nutrition, Clinical and Organic chemistry, Biochemistry, Molecular biology, Laboratory medicine, Immunology, Endocrinology, physiology and experimental science published in CAS journals
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