The document outlines the key contributions of an individual in setting up an in-house clinical data management system (CDMS) at a company. The individual identified requirements, screened various CDMS options, created documentation, facilitated negotiations with vendors, ensured proper implementation including validation, and maintained documentation for auditing purposes. They also contributed to outsourced project management, in-house project management, process enhancement, and mentoring team members.

1.  Key contribution for setting-up of In-house Clinical Data Management System (CDMS)
 Identified the scope of work for setting up CDMS.
 Screened various CDMS based on business requirement and budget.
 Created business case as well as user requirement document for CDMS.
 Screened the CDMS in detail in terms of 21 CFR part 11 requirement and other required features such as key features and customized reports etc.
 Shortlisted CDMS based on 21 CFR par 11 compliance, budget, business requirement, vendor service, scope of CDMS utilization and functions.
 Involved in due diligence of CDMS such as auditing to CDMS vendor, taking opinions from industry experts etc.
 Shared details audit report with management and shared audit report to vendors for CAPA.
 Negotiated financials aspect with vendor.
 Facilitated the final agreement between DRL and vendor and ensured scope of work well define between both parties.
 Coordinated with IT team to ensure are IT pre-requisite are fulfilled for CDMS.
 Coordinated with internal IT QA for compliance part.
 Reviewed and approved CDMS implementation plan and made sure vendor adhere to plan and timeline with quality deliverables.
 Reviewed and approved Operational Qualification (QQ) and performance Qualification (PQ) document.
 Involved in Installation Qualification (IQ) of CDMS.
 Performed Operational Qualification (QQ) & Performance Qualification (PQ) using test cases for validation and production serves.
 Ensured all the CDMS implementation documents are maintained properly for future use as well as audit purpose.
 Ensured timely payment to vendor against the milestone achieved as mentioned in agreement.
 Key contribution for Outsource projects
 Budget finalization for project.
 Review and evaluating of proposals from various CROs.
 Audit visit to CROs for further screening and sharing observation with CROs.
 Negotiating with CROs on financial aspect and deliverables.
 Finalization of CRO based on budget, service and timeline.
 Review of sponsor CRO deliverable contract document.
 Overall supervising the projects and highlighting to management for foreseen risk.
 Taking periodically updated report and sharing the same with management.
 Review and approval of key documents such as CRF, DMP & DVP etc.
 UAT of database (for EDC projects).
 Participating in meetings to share or raise any feedback or suggestion.
 Key contribution for In-house projects
 Working as project lead for CDM projects.
 Tracking the project progress and updating the same to the management as well as highlighting the foreseen risk to the management.
 Task allocation to team members.
 Communication with key stakeholders of project such as clinical operation team, IT and Bio- statistician etc.
 Review and approve Case Report Form designing.
 Review and approve key documents such as Data Management Plan (DMP), CRF annotation and Edit checks document, test script and other database designing documents etc.
 Review and approve of key project guidelines such as date entry, data validation, third party data reconciliation, database lock etc.
 Involve in designing of database.
 Perform User Accept Testing (UAT).
 Perform Discrepancy Management
 Key contribution for Process Enhancement

2.  Identifying, creating and review of new CDM SOPs.
 Ensuring team members adhere to the compliance.
 Facilitating internal and external audits.
 Sharing CAPA with auditors post audits, and ensuring observations will not repeat in future.
 Others:
 Mentoring to new or existing team members on CDM activities.
 Sharing real time feedback to team members to ensure that error identified right time.
 Sharing team member’s performance feedback to management for bi-annual and annual appraisals.
 Conducting knowledge sharing session.