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Job Details
Novartis
Preclinical Study Monitor, NIBR ( Cambridge, MA)
Job Description
$9.0 billion R&D spend to develop breakthrough medicines! $9.0 billion R&D spend to develop breakthrough medicines!
At Novartis, our Preclinical Safety (PCS) scientists provide world class safety profiling and assessment, applying all available scientific tools to optimize drug discovery and development. As part of the renowned Novartis Institutes for BioMedical Research (NIBR), PCS partners with experts across the globe to ensure excellence in addressing human-relevant safety questions.
As a Study Monitor in the Preclinical Safety group within NIBR's Translational Medicine team you will be appointed to each outsourced preclinical study based on relevant technical expertise, designated disease area and/or scientific background knowledge and act as the primary scientific contact for the Study Director at the Contract Research Organization (CRO).
Your responsibilities will include but not be limited to:
-oversee the progress of the study and for ensuring that the study is conducted, recorded and reported according to the study protocol
-ensure the study is compliant with the appropriate GLP regulations, Novartis animal welfare policies, CRO in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations.
-Resolve study related issues, liaise with internal experts and inform the appropriate people in a timely manner as it is pivotal to the performance of this role. The study phases and sample delivery timelines should be strategically overviewed and tracked to ensure that internal contributor reports are delivered to the CRO on time and that the CRO meets its agreed main reporting timelines.
This is an on-site role to be based in Cambridge, MA
At Novartis, our Preclinical Safety (PCS) scientists provide world class safety profiling and assessment, applying all available scientific tools to optimize drug discovery and development. As part of the renowned Novartis Institutes for BioMedical Research (NIBR), PCS partners with experts across the globe to ensure excellence in addressing human-relevant safety questions.
As a Study Monitor in the Preclinical Safety group within NIBR's Translational Medicine team you will be appointed to each outsourced preclinical study based on relevant technical expertise, designated disease area and/or scientific background knowledge and act as the primary scientific contact for the Study Director at the Contract Research Organization (CRO).
Your responsibilities will include but not be limited to:
-oversee the progress of the study and for ensuring that the study is conducted, recorded and reported according to the study protocol
-ensure the study is compliant with the appropriate GLP regulations, Novartis animal welfare policies, CRO in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations.
-Resolve study related issues, liaise with internal experts and inform the appropriate people in a timely manner as it is pivotal to the performance of this role. The study phases and sample delivery timelines should be strategically overviewed and tracked to ensure that internal contributor reports are delivered to the CRO on time and that the CRO meets its agreed main reporting timelines.
This is an on-site role to be based in Cambridge, MA