Job title: Clinical Data Manager
Job description: My client is a niche Device & Technology company based in the US. They’re looking for a Clinical Data Manager to be fully remote based along the east coast. They’re a small start-up company developing new technology to support the real time excision of tumour tissue during cancer surgeries.
– Responsible for oversight and execution of data management activities for assigned clinical trials including data timelines and key deliverables
– Manages and supports vendors contracted to assist in the conduct of the clinical trial, including, but not limited to CROs, Labs, ePRO, and IRT
– Prepares reports, data charts and other presentation materials as needed
– Contribute to preparation of reports and analyses reflecting study progress, enrolment trends and appropriate recommendations and conclusions
– Experience with EDC system(s) is required, Medrio preferred
– Manages data management CRO and oversees database development, UAT, data import specifications, CRF completion guidelines, data entry guidelines, data management plan development according to ICH/GCP/CFR guidelines and other current regulatory requirements and best practices
– 5 years’ experience working as a Clinical Data Manager in the life science/pharmaceutical/medical device industry
– Oncology or imaging experience preferred
– CRO experienced preferred or has managed CROs before
– Knowledge working on clinical trials following FDA/ICH guidelines
Job date: Sat, 27 Feb 2021 08:02:52 GMT
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