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.


Responsibilities;

- 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


Responsibilities;

- 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