Imaging Operation Lead

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