ERT

Team Lead, Imaging QC

Job Location US-OH-Cleveland
Shift
40
Type
Regular Full-Time

Overview

The Team Lead Imaging QC will be responsible for staff management and/or the direction, management or oversight within the areas of image quality and related subject positioning and acquisition methods within client projects to assure high quality, on-time, and on-budget services and promoting excellent customer service.

Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  1. Serve as subject matter expert for the areas of Imaging QC providing support for Project Management team members, educating customers on the related operational services, and driving synergies across service lines.
  2. Manage designated Image PRN QC staff, which includes:
  • Ensuring proper training is executed and documented
  • Conducting reviews of system set-ups and documents to ensure high quality of deliverables in accordance with quality standards and SOPs/SWIs
  • Coordinating routine status meetings to facilitate communications, monitor workload, and
  • provide forecasting guidance
  • Collecting and monitoring defined staff metrics
  1. Independently lead and perform the efforts within Image QC during the Planning and Setup, Monitoring, and Closeout phases of study management to include:
  • Contribute to, support the development of and/or understand and adhere to the study specific documents and/or elements of the Imaging Charter.
  • Coordination of the various teams working in support of the Study (ex: Image QC, Site and Reader Management, etc.)
  • Understand, be able to explain and have necessary proficiency in the software and tools used within the Imaging Study
  • Performing image quality review, redaction and/or image prep as specified by the direction of defined study specific parameters within the study required timelines.
  • Issuing queries and performing routine follow-up with study sites for resolution, informing Imaging Project & Site Management of trends or issues jeopardizing study timelines.
  • Collaborate with the cross functional Imaging team members and authorities to ensure the specification and use of the appropriate equipment and when a contracted service.
  • Creating, maintaining and distributing reports or spreadsheets in support of one or more studies.
  • Archiving study data and documentation through various methods.
  • Appropriately setting and fulfilling customer expectations
  1. Execute and monitor project timelines and manage the financial components of Image QC within each study, which include collaboration with the study team on:
  • Budget reviews
  • Revenue forecasting
  • Scope changes
  • Invoice reconciliation
  1. Identify potential study risks and mitigations, and escalate as appropriate.
  2. Manage internal/external dialogue and promote collaboration to foster a positive team environment, effective communications, and efficient use of resources to meet study timelines and contractual obligations.
  3. Develop and apply problem solving strategies to address client issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations.

 

OTHER DUTIES AND RESPONSIBILITIES:

  1. Read, comprehend and be able to summarize and comply with various study documents (i.e. Clinical Protocol, contracting documents, budget, components of the Imaging Charter) to understand and communicate the role of imaging within the assigned studies.
  2. Provide accurate and detailed project time reports, complete assignments within prescribed and committed timelines, seeking assistance and support when necessary.
  3. Ensure compliance with timely training completion/documentation.
  4. Create content and present at Investigator Meetings, site initiation or other meetings as needed.
  5. Attend client meetings with Business Development and/or Operational teams to present Imaging services and expertise, as needed and participate in sales initiatives to generate incremental revenue.
  6. Serve as the Image QC point of contact for operational readiness regarding new product initiatives when assigned.
  7. Consistently and dependably engage in the process of critical thinking in order to formulate recommendations, implement approved decisions and prevent issues or escalations.
  8. Assist with training new members of the Imaging team.
  9. Other related assignments, projects and tasks as assigned.

Qualifications

QUALIFICATIONS AND SKILLS NEEDED:

  1. Bachelor Degree and/or proven demonstrated Project Management skills or experience within the industry, including expertise in image acquisition, image quality and imaging workflows. Extensive experience in lieu of degree will be considered. Active, in good standing certification or registry in one or more specific imaging modalities/areas is preferred.
  2. Over four years of experience in imaging, project management and or project leadership experience with additional experience in the workflows within one or more of: clinical trial management, healthcare management/operations, pre-clinical research, radiologic or a related science.
  3. Ability to establish priorities for both self and direct reports, work independently, prioritize appropriately and proceed with objectives with minimal supervision in order to deliver high quality at high productivity.
  4. Demonstrated ability to mentor and lead staff
  5. Excellent verbal and written communication skills, including the ability to communicate effectively in English. Must also be computer literate with application knowledge of PACS, image analysis software, Microsoft Word, Excel, PowerPoint, database querying, e-mail and electronic calendar.
  6. Detail oriented and demonstrated responsiveness to inquiries and requests.
  7. Knowledge of risk management techniques and the ability to analyze and resolve problems.
  8. Experience working in a regulated industry, preferably within pharmaceutical, medical device or medical imaging.
  9. Excellent communication and organizational skills with a strong ability to collaborate in English (both verbally and written) with teams of research scientists, bioinformaticians, software developers, and external collaborators. Will have frequent interaction with clients, suppliers, management and staff including the requirement to present study workflows and/or processes.
  10. Must have a valid passport and the ability to travel approximately 20%.

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