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Senior Director, Clinical Data Management
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- Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics.
- The Senior Director, Clinical Data Management is accountable for the strategic leadership and functional management of all CDM deliverables in adherence to company SOPs and ICH/GCP. This role manages the CDM function, ensuring the development and readiness of personnel to deliver on existing programs while also being forward-looking and innovative.
- Responsible for performing data management oversight activities in support of Leap Clinical Studies by overseeing the activities of the CRO DMs, from study start-up through to study closeout, to ensure adherence to scope of work and service agreements, and that the deliverables are on time, within budget and are of a high quality.
- Lead in the establishment of CDM processes, including identifying, authoring SOPs and Work Instructions to ensure regulatory compliance, GCP, and ICH.
- Ensure archival and inspection readiness of all Data Management Trial Master (TMF) documents.
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