As an External Network Manager for the Imaging group, manage business operations and have broad responsibility for budgets, contracting, project management and tracking for assigned projects within the Imaging group.
Work with TREC Imaging scientists to provide a seamless interface of TREC imaging with preclinical and clinical operations teams for imaging trials and preclinical and clinical studies containing imaging components across TAs.
Responsible for developing, implementing, and maintaining information and communications strategies & approaches to promote collaboration and project success within the Imaging group as well as between internal & external stakeholders.
Management and oversight of processes and documentation between Imaging and internal & external stakeholders. Manages review of internal documents with an imaging component and of technical documents from external imaging partners.
Serves as Takeda’s main administrative point of contact for building and maintaining the External Imaging Network (outsourced) for assigned Imaging CROs (both preclinical and clinical); Academic Imaging Centers (both, preclinical and clinical), and Image Archive & Analysis vendors.
As a subject matter expert in Imaging, actively participate in project operational team meetings to ensure that project priorities and timelines with respect to imaging are being met and to assure TREC imaging relationships are functioning appropriately with regards to studies containing imaging components.
In conjunction with Outsourcing, Legal and Clinical Operations, manage and actively provide imaging operational support for CDAs, consultancy agreements with Imaging KOLs and MSAs for imaging CROs and other imaging-related vendors to ensure timely availability of their services
Collaborate with imaging CROs and academic center imaging activities to ensure project timelines , resource needs and budgets meet Takeda expectations
Work with TREC Imaging scientists to coordinate and facilitate timely incorporation of imaging components into protocol synopses, full protocol and informed consent documents
Work closely with CSMs to implement imaging-specific component of research protocols
Assist Outsourcing with technically accurate descriptions of requested imaging services /timelines in RFPs generated for imaging CROs
Work with regulatory to ensure compliance of imaging biomarker trials
Work with CMC to ensure timely material supply of precursors for PET studies
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BS/BA degree in biology, allied health, pharmacy or related life science
Experience as a nuclear medicine or MRI technologist in a clinical practice setting, or alternatively management and technical experience in an imaging company or CRO performing imaging in clinical trials
Experience in drug development processes in the pharmaceutical industry strongly desired
Financial operations management strongly desired.
Must have strong project management and organizational skills
Must have excellent interpersonal skills as well as good negotiation and influencing skills
Good analytical and problem-solving skills
Strong written and verbal communication skills
Powerpoint, Excel, Word and MS Project skills
Image Technologist certification (or related field) preferred but not compulsory ( Nuclear Medicine or MRI preferred)
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