Imaging Project Manager - Blue Earth Diagnostics Inc

Imaging Project Manager page is loaded## Imaging Project Manager locations:
Needham, Massachusetts, 02494, USAtime type:
Full time posted on:
Posted Yesterday job requisition
*** About Blue Earth Diagnostics:
*** Blue Earth Diagnostics is an established molecular imaging company focused on providing innovative, well-differentiated diagnostics solutions, informing patient management, and driving future therapies in cancer. Formed in 2014, Blue Earth Diagnostics’ success is driven by our management expertise and agility, supported by our demonstrated track record of rapid development and commercialization of PET radiopharmaceuticals. Blue Earth Diagnostics’ clinical focus is exclusively in cancer.

Blue Earth Diagnostics is a subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging.

Blue Earth Diagnostics is an established molecular imaging company focused on providing innovative, well-differentiated diagnostics solutions, informing patient management, and driving future therapies in cancer. Formed in 2014, Blue Earth Diagnostics’ success is driven by our management expertise and agility, supported by our demonstrated track record of rapid development and commercialization of PET radiopharmaceuticals. Blue Earth Diagnostics’ clinical focus is exclusively in cancer.

Blue Earth Diagnostics is a subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging.

- ** Job purpose
** A key member of the Blue Earth Diagnostics Research & Development (R&D) team, the Imaging Project Manager will support the development of new diagnostic radiopharmaceutical agents throughout development phases I-IV in accordance with IHC-GCP and Standard Operating Procedures (SOP’s).This position will operate on a hybrid work schedule, with the expectation of working onsite 3 days a week in our office located at 197 First Avenue, Needham, MA.
** Main Responsibilities, Activities, Duties and Tasks
*** Provide oversight of third-party imaging core lab.
* Lead the imaging interface with the Clinical CRO, site monitors, study team, etc.
* Support clinical operations in the setup, execution, and close-out of clinical studies, including the provision of technical expertise for the development of imaging and radiopharmaceutical related study documents (e.g., imaging and dosimetry components of the protocol, data acquisition manuals, imaging charter, etc.).
* Coordinate closely with the medical physicist assigned to studies to ensure operational translation of scientific and technical advice and requirements.
* Coordinate closely with other functions including Clinical Science, Biostatistics, CMC and Regulatory Affairs.
* Ensure regulatory inspection readiness in collaboration with the study team.
* Maintain thorough and up-to-date knowledge of imaging techniques, clinical information, and product data within the diagnostic and therapeutic radiopharmaceutical arena.
* Support the design of training materials and conduct training for Medical Affairs and customers in preparation of product launch.
* Support Medical Affairs in organizing medical education activities at conferences and external meetings.
* Attend national congresses and meetings, as required.
* Maintain current professional certifications.
* Travel – Up to 40% mostly within the US, with occasional international travel
* Other duties as determined by business needs.
** Education/Qualifications
*** Undergraduate or degree program in radiography, physics or a related discipline or a Certified Nuclear Medicine Technologist
** Professional Experience, Knowledge, & Technical Skills
*** Experience in clinical Positron Emission Tomography and/or Nuclear Medicine
* A minimum of 3 years’ work experience in PET or PET/CT, ideally with a current certification.
* In depth expertise and hands on experience in scanner qualification (phantom imaging and analysis) and image QC.
* A background in research and development, in a pharma or biotech company or Imaging Core Lab/CRO, is preferred, ideally in diagnostic radiopharmaceutical development
* Experience in global clinical trials is preferred, ideally with experience from early to late-stage drug development
* A high degree of…