Vacancy expired!
Location: Princeton, NJ Description: Our well known Pharmaceutical client is currently seeking a Clinical Trial Business Capability Lead who will provide overall leadership and governance of a GDO business capability end-to-end, encompassing process and technology strategy implementation.
This job will have the following responsibilities:- Serves as the Business Capability Lead/Subject Matter Expert for the business capability, including system/technology, regulatory inspection/internal audit.
- Serve as the SME of for hCelgene RAVE EDC Study build, amendments, data extracts, reporting and new regulation impact assessments.
- Serve as the SME for data interfaces between hCelgene Rave EDC system and other internal/ external solutions.
- Partners with R&D functions, internal and external partners including Contract Research Organizations (CROs)/vendors on strategy, development, implementation, and oversight of enhancement to current business capability.
- Works broadly across Global Clinical Operations, Global Clinical Development, Global Data Management, Centralized Monitoring, Regional Clinical Operations, Clinical Trial Strategy, Quality & Compliance, and IT to leverage digital expertise and capabilities across the enterprise.
- Bachelor's degree required with an advanced degree preferred.
- Minimum of 8 years of direct experience independently leading and managing clinical trial activities plus 1-2 years in a leadership position directing system, process, program or quality activities.
- Knowledge of Google Cloud Platform/ICH guidelines, regulations.
- Experience with Electronic Data Capture (EDC) best practices and principles including Medidata RAVE EDC, including several modules in those platforms to support data capture, safety reporting, central monitoring, and clinical data reporting.
- Experience with Regulatory and Compliance requirements with regards to the Clinical Data Management.
- Ability to effectively respond to regulatory trends, internal audits, inspection activities including root cause analysis/Corrective Action/Preventive Action (CAPA) plans for any findings.
Vacancy expired!