Radhika K

• Responsible with supervision for the timely and quality creation of electronic Case Report Forms (eCRFs) according to finalized protocols and study design specifications for Electronic Data Capture (EDC) studies
• Leading study build end to end activities including other addon modules and deliver the project as per defined timelines.
• Mentoring associates on different modules and giving hands on activities to level them up in their role
• Timely and quality programming of field derivations, edit checks, consistency checks, validations, procedures and rules
• Responsible with supervision for the timely and quality programming of data extraction programs
• Involve highly study kick-off meeting and contribute towards optimization of database and timeline accordingly
• Supervision of the timely and quality creation of study level documentation for all modules used while study build activities
• Responsible with supervision for study database documentation maintenance in the electronic Trial Master File (eTMF)
• Responsible with supervision for the timely and quality system testing and Quality Control (QC) of specified deliverables
• Participates in projects to automate, simplify and innovate in order to ensure that the team is industry leading
• Acquired base SAS training and currently working on SAS to deliver listings

• Takes complete ownership of the study and POC for PSS activities and ensures zero escalation.
• Understands and knowledgeable with overall process and flow of activities
• Effective Coordination and communication with PSS stakeholders and DTL
• Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities, and deliverables.
• Develop and maintain good communications and working relationships with teams and external clients.
• Reports the quality of the study on a timely manner.
• Works on identifying the resourcing needs on a timely basis.
• Responsible for understanding the client’s requirements, devising, and proposing a feasible solution.
• Create & maintain project documentation including issue trackers, delivery trackers & resource utilization.
• Subject matter expert (SME) of tSDV module within Rave.
• Was involved every step with the leadership of the project, providing recommendation on approach and execution.

• Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems.
• Provide technical expertise in conjunction with internal and external clients.
• Program, test, and document databases in accordance with programming standards and validation procedures.
• Program database manipulation and transfers of data for internal and external clients.
• May assist IT in developing and implementing new technologies.
• May assist IT in testing and evaluating new upgrades to technologies.
• May assist in developing, revising, and maintaining core operating procedures and working instructions.
• Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities and deliverables.
• Develop and maintain good communications and working relationships with teams and external clients.
• Interact with corporate team and CDM team members to negotiate timelines, responsibilities, and deliverables.
• Serve as Lead Programmer on the corporate team.

Developing electronic data entry screens (eCRF’s) based on trial specific requirements including:

• Developing protocol specific visit components
• Developing and maintaining code lists, panels and export tables from annotated CRF’s, SAS Proc Contents files, internal standards, departmental standards and/or customer specific formats
• Assisting with metadata analysis determining the best implementation strategies within the operational database, which includes providing mapping documents for elements requiring secondary programming carried out by others
• Presenting final deliverables, providing rationale for decisions and explaining thought processes. Provide alternate solutions, as needed
• Developing blank and annotated case report forms (CRF’s) based on customer requirements, incorporating the elements of the study created during the study design process
• Developing SDTM annotated CRF’s
• Developing study specific workbooks
• Developing and formatting individual patient profiles according to customer requirements
• Assists in the design and development of custom edit checks by gathering requirements for protocol specific implementations of Express™ in accordance with edit check specifications
• Writing, validating, and implementing protocol specific edit checks
• Developing custom reports based on project management requests
• Importing protocol specific lab data based on customer/laboratory specifications
• Periodically performing study maintenance, including, but not limited to: edit check fixes, batch edits, creating forms updates, and study design changes
• Assisting the Study Quality Representative in the testing of protocol-specific edit check

• Supporting clinical data management team.
• To perform clinical database programming which includes edit check programming and eCRF build
• Quality review and Testing of database and Edit checks.
• To work on different areas of the tool and taken initiative to guide team to proceed.
• Supports clinical database setup and edit check programming within targeted timelines.
• Supports quality control measures in conjunction with Clinical Data Management (CDM) and other cross-functional groups
• Complete database setup and validation programming within targeted timelines
• To provide coaching and mentoring to the trainees and database programming team members
• Worked on migrations through which updates to existing PROD data will be implemented by performing impact analysis.
• As a clinical database programmer, works to meet specific project, program and departmental goals Code, test and document databases as per programming standards (Edit Checks) and clinical validation policies.

• With guidance, develop eCRFs, Edit checks as per the Data Management Plan.
• Understand and comply with core operating procedures and working instructions
• Continuously look for opportunities to improve efficiency of tasks and quality of deliverables.
• With guidance, ensure that the quality has been met as agreed upon timelines and deliverables
• Involved in the Quality of review for the eCRFs and Edit Checks Categorization.
• Performed Quality Testing of the edit checks and supported in resolving issues.