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Imaging Operation Lead
Parexel International Corporation
Shanghai, Shanghai Municipality, China
Imaging Operations Lead is responsible for assisting the Project Manager in internal as well as external communication. Imaging Operations Leads is coordinating the worldwide team effort of executing the technical and clinical functions required by the study protocol and leading the study team to facilitate study completion and meet quality and timelines.
Key Accountabilities:
Project Management tasks:
Assist in leading team to meet client deliverables on time and within budget
Alert the project manager of any resourcing or timeline issues (e.g. reviews backlog reports, reviews resourcing sheets and provides feedback to PM and IRM)
Develop reports for management and clients / Provide direction to imaging assistants for on-going report creation
Ensure team members are trained on imaging protocol and operation procedures
Support and deputize for project manager during external study team calls (e.g. regular calls with client or clinical CRO)
Support project manager in conducting the kick-off meeting and other study team meetings with internal and external study team members.
Organize, prepare, and conduct training sessions on medical imaging processes with CRAs, sites and other internal and external study team members
Prepare and conduct trainings and presentations on medical imaging processes at investigator meetings
Prepare and present slides on medical imaging processes during bid defense meetings
Support project manager in creating the User Requirements for the Tracking application
Monitoring tasks:
Ensures that site qualification, image processing and query management are performed according to the global guidelines such as SOPs and work instructions and within the defined timelines
Provides work direction and support to IRAs and IAs regarding site qualification and image processing steps
Regularly review the status of site qualification, image processing, query management
Act as a point of escalation for site related issues
Support IRA and IA team members on answering site queries and requests
Notify PM if team requires additional training around core capabilities or study specific tasks
Assist in determining requirements for image processing software. Work with technical staff towards implementation
Data management tasks
Support project manager during Medical Acceptance Testing of the Analysis application
Create Data Change Requests and check that they were properly executed
Assist with managing the data reconciliation process
Reviewer Management:
Assist with reviewer management activities
Assign cases for independent review / Provide direction to IA for case management
Communicate with internal and external reviewers to ensure the review timelines are met
Monitor the status of the reads and communicate back to the reviewers / PMs as necessary
Assist with delegation of project work relating to image processing and site support
Interface with clients in project manager’s absence
Act as liaison with 3rd party providers and/or consultantsQualificationsAbility to effectively provide work direction to people
Excellent delegation skills
Strong communication skills
Clinical trial experience preferred
Medical Imaging experience required
Excellent grasp of SOPs
Excellent organizational skills
Detail orientated
Computer literate and familiar with the use of word processing, spreadsheet, presentation software and basic database applications
Knowledge and Experience:
Previous Team management experience preferred.
Good knowledge on Clinical Trials preferred.
Education:
Bachelor’s Degree in a biological science, health science, technology or pharmacy or equivalent work experience
Job posted: 2020-11-06