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Clinical Study Manager
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- Develop project cross-functional, integrated study plan to study start up (in-house) and validate and manage to the overall study plan provided by the CRO. Participate in site selection and site qualification with (study team and CRO).
- Contribute to operational delivery aspects of the protocol and take a document review & coordination role for the protocol and amendments.
- Act as the project manager of the clinical study team to liaise and coordinate with internal stakeholders to ensure cross functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan.
- Oversee CRO study start-up activities and coordinate with functional group to ensure that essential site documents are collected and sites are initiated per plan.
- Provide oversight of the transmittal of trial and site level documents to the Daiichi Sankyo Document Control Center (DCC) in support of the Trial master File (TMF).
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