Ruchisha Patel

About Ruchisha Patel

Detail-oriented and results-driven professional with experience in both hospital and pharmaceutical settings, specializing in clinical trial operations. Strong understanding of clinical research processes and regulatory requirements, with a proven ability to collaborate across cross-functional teams. Recognized for building effective relationships, managing priorities with precision, and maintaining professionalism in fast-paced environments. Committed to supporting the advancement of clinical research through organized execution and continuous growth.

Experience

1. Senior Clinical Trial Associate

   Genmab

   Apr 2025 — Present · Princeton, NJ, US

   Act as a key operational partner to the Global Clinical Trial Manager, supporting end-to-end execution of global Phase 1 through Phase 3 Oncology clinical trials across diverse therapeutic areas• Lead the setup, oversight, and closure of Sponsor eTMFs at trial, country, and site levels, ensuring compliance, accuracy, and audit readiness in alignment with ICH-GCP and regulatory standards• Manage TMF health by tracking milestones, performing monthly quality reviews and bi-annual spot checks, and proactively resolving documentation issues to support inspection readiness• Coordinate and document governance and cross-functional meetings, including scheduling, minute-taking, action item tracking, and eTMF filing to ensure alignment and transparency across stakeholders• Maintain robust study documentation processes, including authoring and updating TMF plans, reports, and trial deliverables to support study continuity and compliance• Support CSR development through accurate compilation and submission of required appendices• Serve as a Subject Matter Expert (SME) for critical trial systems and processes, contributing to training, knowledge sharing, and continuous process improvement initiatives• Partner in the development and refinement of SOPs and Work Instructions, ensuring operational excellence and regulatory alignment• Mentor junior team members and contribute to process optimization by leveraging cross-functional collaboration, risk mitigation strategies, and operational insights

Education

• Seminole State College of Florida

  Associate of Arts (A.A.), General Studies

  2010 — 2012

• University of Cincinnati

  Master of Health Administration, Health/Health Care Administration/Management

  2016 — 2018

• University of Central Florida

  Bachelor of Science (BS), Health Information Management and Informatics

  2013 — 2015

Skills

• Icd-9
• Healthcare Management
• Strategic Planning
• Ehr
• Emr
• Customer Service
• Medical Terminology
• Informatics
• Social Networking
• Icd-10
• Citrix Xendesktop
• Healthcare
• Time Management
• Healthcare Information Technology
• Team Building
• Management
• Microsoft Excel
• Powerpoint
• Microsoft Word
• Team Leadership
• Data Entry
• Public Speaking
• Medical Records
• Leadership
• Research
• Medical Coding
• Social Media
• Allscripts
• Training
• Healthcare Information Technology (Hit)
• Microsoft Office
• Hipaa