Clinical Data Manager

Company
Volt
Location
Massachusetts, Massachusetts, US
Salary
Competitive
Posted
25 Feb 2021
Closes
27 Mar 2021
Ref
Jp2LAHYiNgtm
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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

Apply now