Koushik Govindarajan

About Koushik Govindarajan

I am an experienced clinical researcher with a focus on utilizing imaging techniques and data analysis to achieve clinical endpoints in oncology clinical trials. I thrive in a multi-functional environment, collaborating seamlessly across multiple stakeholders in the clinical trial space. Experience also includes vendor selection & management, study start up activities and contributing to FDA submissions.My strong background in medical imaging, combined with experience in small biotechs and large pharma companies, enables me to add value across various stages of the clinical trial landscape. Experience working with clinical sites across the Americas, EU, APAC and Asia has helped me understand the nuances of geographical and cultural differences in the execution of clinical trials across the globe.Core Competencies: Multi-modality Imaging | Clinical Development | Oncology | Tumor Progression & Response Assessment | DICOM/PACS | Clinical Operations | Trial Design | RECISTSkillset: Veeva Vault eTMF | InForm | SPECTRUM | JReview | TrialMax ePRO/eCOA | Medrio

Experience

1. Contractor - Clinical Science Support

   Kelly Science, Engineering, Technology & Telecom

   Sep 2024 — Present

   Clinical point of contact for scientific issues for global sites across EU, APAC, North America for Phase 3 solid tumor oncology trial• Perform Medical Monitor activities - review of SAE, query generation and medical monitoring plan (MMP)• Utilize imaging data to identify disease progression towards critical trial endpoints • Monitor data issues requiring clinical input and contribute to interim analysis and database lock activities• Monitor central lab reports and other external data for safety and critical values• Overall support of clinical trial team to efficiently complete global trial deliverables

Education

• Wayne State University

  Master's Degree, Biomedical Engineering

  2003 — 2005

• UC San Diego Extended Studies

  Certificate, Regulatory Affairs for Medical Devices

• Madurai Kamaraj University

  Bachelor of Engineering (B.E.), Electrical and Electronics Engineering

  1999 — 2003

• University of Houston, C.T. Bauer College of Business

  Master of Business Administration (M.B.A.), Business Administration, Management and Operations

  2014 — 2016

Skills

• Mri
• Xlminer
• Good Clinical Practice (Gcp)
• Image Processing
• Signal Processing
• Management
• Medical Imaging
• Data Analysis
• R&D
• Clinical Trials
• Biomedical Engineering
• Jmp
• Project Management
• Matlab
• Medical Devices
• Clinical Research
• Image Analysis
• Powerpivot
• Business Strategy
• Life Sciences
• Sap Erp
• Microsoft Office
• Tableau
• Research
• Microsoft Excel