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 environment

- Coordinating with vendor representative for recent 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