Srijil Kadan

• Offer expertise in employing data management practices to create databases that support high-quality international studies. Manage vendor relationships to ensure optimal database design and delivery, focusing on cost-effective solutions for company.
• Accountable for overseeing the creation of global clinical study databases and managing study-specific tasks, utilizing internal matrix management and external oversight of CROs and consultants. Responsible for executing internal projects focused on research areas of interest aligned with R&D goals
• Lead operations team meetings, meeting frequently with study leads of coding, SAE Recon team, EDS team to ensure that all deliverables are planned, coordinated interdepartmentally, and proactively identifying potential risks and mitigations
• Effectively communicating data-driven discussions to achieve database lock dates with highest possible data quality
• Specification writing for CPT, MPR, PD listings, DM listings, SAE recon listings & DVS Listings
• CPPC activities and to complete deliverables within timeline
• Identifying misfiring checks & conditions and communicating the same with CDL
• Understanding and adhere to all assigned ICON SOPs and working procedures
• Perform UAT activities
• POC for studies and coordinating all regular activities and communicating issues with CDL
• Compile and distribute necessary study documentation and maintain accurate and complete study files in accordance with all applicable procedures
• Perform Quality Reviews and appropriately address all issues
• Effectively mentor less experienced staff

This may include assisting and guiding new personnel during their initial training period

• Generate, review for accuracy, and distribute status reports as requested
• Operating as Data Manager within team
• Represent Data Management at internal / external meetings as appropriate
• Independently and accurately prepare database test documentation and test data entry screens
• Identify and accurately resolve all workflow or clinical data discrepant issues
• Update Data Management Plan
• Create and update eCRF Completion Guidelines

• Key Interactions with internal functional representatives and study teams as well as external consultants and CROs undertaking outsourced activities. Externally represent Mundipharma at conferences and industry-wide initiatives.
• Process improvement and development within Data Science. Implementation of process changes in line with regulation and guidance changes
• In collaboration with the Trial Lead, ensure operational excellence across all DM deliverables
• Assist with all data management activities according to Client quality expectations
• Attend Lead operations team meetings, meeting frequently with the study leads of coding, Safety team, EDS team to ensure that all deliverables are planned, coordinated interdepartmentally, and proactively identifying potential risks and mitigations
• Coordinating with different internal stakeholders such as Programmers, Validation team lead and Coders to ensure that all the assigned activities are on track to be delivered to the customer and meet the timelines
• Ensure Architect load spreadsheet is consistent with the requirements and production database
• Perform independent review of CRF data for completeness and accuracy
• Mentor / Coach in training of junior resources on project-specific, global, standardized data management processes
• Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRF Completion guidelines, Data Management Plans
• Create specification and test cases for custom study reports and listings
• Provides input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms
• Update the Data Management Plan under the guidance of the LDM
• Performs QC on all aspects of work performed in DM Operations to ensure that data quality and integrity is maintained
• Feedback constructively on relevant issues and initiate process review as appropriate
• Run study metrics and KPIs as appropriate for the operations team to review for productivity, quality and on time delivery
• Create and update eCRF Completion Guidelines
• Reconciliation: Reconciliation activities which includes SAE, Lab reconciliation
• Raise database access and revoke requests for study team member.

• Primary project contact for small to mid-size two or more studies
• Coordinate work allocation and submit daily and weekly task progress to Project Lead
• Act as India point of contact for providing updates on assigned data cleaning tasks to India DM team on project
• ECRF UAT
• ECRF completion guideline creation
• Query Processing
• Listing Review
• Manual Review
• SAE Reconciliation
• Weekly/Monthly Status report preparation.