Senior Project Manager

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.

1. Provide Assistance for Setting up Medical Imaging Laboratory Facility
2. Assist in development of Imaging Data Flow
3. Feasibility Assessment for Imaging Component of the Project to identify Competent Investigators Site
4. Plan and Perform Site Selection and Site Initiation Visits in coordination with Project Team for Imaging Component of the Project
5. Schedule and/or Impart required Training to the Site Staff (for Image Acquisition Guide and Image Upload Procedure)
6. Customize Imaging Project Specific Documents which includes Imaging Workflow Guide, Site Operations Manual, and Independent Review Charter etc.
7. Prepare and Maintain the Imaging Master File before Initiating the Project and throughout the conduct of Project, as necessary
8. Ensure availability of Essential Documents necessary during Process of Identifying and Finalize the Independent Reviewers for each Project
9. 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
10. Manage the Independent Review Process, Setting up Training of Independent Reviewers, Managing Assignment of Cases to the Reviewers and Reviewer Time
11. Keep track of Imaging Studies to be received from the Site
12. Perform Quality Check of Images acquired by sites to ensure compliance with Image Acquisition Manual
13. 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
14. Provide support for Internal/External Audit/Inspection
15. Conduct each activity as per SOPs of the department
16. Help maintain and update all the systems and SOPs in the department
17. Train the staff on all to Project related aspects and related SOPs & giving inputs for developing systems
18. Performing post-implementation (in-use) review for software i.e. evaluating software implementation in live environment
19. Coordinating with vendor representative for new user requirements, incidences etc
20. Tracking software performance
21. Preparing Responsibility Matrix of software
22. Being a single point of contact for overall maintenance and support to be availed for software from vendor

12-15 yrs. experience in Medical Imaging

Masters (Lifesciences Background)