Savita Rajpurohit

• Lead highly complex studies & collaborate with respective stakeholders to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing.

• Provide DM project team leadership & potentially serve as a reviewer of project documents such as CSP, CRF completion guidelines, DMP, VDP, etc.

• Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.

• Provides leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations to the internal study team. • Provide support to DM supervisors and managers on the performance evaluation of other team members, provide constructive feedback to aid in career development, interpersonal skills, and achievement of competency standards.

• Potentially interact and collaborate with Clinical, Programming, Statistics, CDM technical support, Drug safety, etc. to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.

•Handling Budgeting/forecasting data of the studies.

•Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team

• Worked on all activities in Start-up, Conduct & Close-out like creating edit check specifications, Screens, Subject Scenario for Screens , Edit Check UAT, drafting DMP, CCG, VDP, working on Queries, Recons, CPT, frequently meeting with Internal & Sponsor team to provide status update.
• Performed several Post production Changes as per CSP amendment.
• Monitored team performance and provided constructive feedback to increase productivity and maintain quality standards.
• Built strong relationships with customers through positive attitude and attentive response.
• Set performance expectations for the team, monitoring progress towards goals and providing constructive feedback as needed.
• Managed conflict resolution among team members, fostering a positive and collaborative work environment.

• Trained junior Clinical Data Coordinators, imparting valuable knowledge and expertise for their professional growth.
• Review CRF / e-CRF data for completeness, accuracy, and consistency via computerized edits and manual data checks. Generate and close/resolve (as appropriate) data queries.
• Identify errors and inconsistencies and resolve them or initiate the resolution as specified in the Data review Plan during the clinical trial conduct

• Created various Excel documents to assist with pulling metrics data and presenting information to stakeholders for concise explanations of best placement for needed resources.
• Performing Study Set up, Conduct & Close Out activities: Writing Edit checks, preparing CRF Completion Guidelines, Linkage of CRF Completion Instructions, Acceptance Testing Of Edit checks, Preparing Reports Specification Document, User Acceptance Testing, Discrepancy Management, Data Validation and Data review Listings, Data Reconciliation of external lab, SAE Reconciliation.
• Generating Quality Control Reports as per defined timelines post analysis of the same. Recommend and facilitate Remedial training and RCA & CAPA sessions on identified defects.
• Provide inputs to improve Accuracy levels and reduction in errors of the operational team.

• To perform Study Conduct & Close Out Activities.

• Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.