Organisational Overview Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. JOB DETAILS Provide Assistance for Setting up Medical Imaging Laboratory Facility

Assist in development of Imaging Data Flow

Feasibility Assessment for Imaging Component of the Project to identify Competent Investigators’ Site

Plan and Perform Site Selection and Site Initiation Visits in coordination with Project Team for Imaging Component of the Project

Schedule and/or Impart required Training to the Site Staff (for Image Acquisition Guide and Image Upload Procedure)

Customize Imaging Project Specific Documents which includes Imaging Workflow Guide, Site Operations Manual, and Independent Review Charter etc.

Prepare and Maintain the Imaging Master File before Initiating the Project and throughout the conduct of Project, as necessary





Ensure availability of Essential Documents necessary during Process of Identifying and Finalize the Independent Reviewers for each Project To Ensure Successful System Validation for Image Quality Check Process and Review Process as per Project Specific Assessment Criteria before initiating Project on Imaging Review Platform

Manage the Independent Review Process, Setting up Training of Independent Reviewers, Managing Assignment of Cases to the Reviewers and Reviewer Time

Keep track of Imaging Studies to be received from the Site

Perform Quality Check of Images acquired by sites to ensure compliance with Image Acquisition Manual

Primary Contact between Site and Project Manager and Communicate with Investigator’s Site for Imaging Study specific Queries and Internal Quality Assurance according to need of project

Provide support for Internal/External Audit/Inspection

Conduct each activity as per SOPs of the department

Help maintain and update all the systems and SOPs in the department

Train the staff on all to Project related aspects and related SOPs & giving inputs for developing systems

Performing post-implementation (in-use) review for software i.e. evaluating software implementation in live setting

Coordinating with vendor representative for new user requirements, incidences etc

Tracking software performance

Preparing Responsibility Matrix of software

Being a single point of contact for overall maintenance and support to be availed for software from vendor Experience 12-15 yrs.

experience in Medical Imaging EDUCATIONAL QUALIFICATION Masters (Lifesciences Background)

📌 Senior Project Manager (Ahmedabad)
🏢 Bioksha
📍 Ahmedabad