Acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups Coordinate the work of the assigned [...]
clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. Oversees site interactions post activation through site closeout. This may include patient r[...]
Interacts with the management team in coordination and collaboration with the enterprise data management office. These activities include the development of processes and operations within the enterprise data management office. JOB RES[...]
site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experienc[...]
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiat[...]
On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary [...]
Responsible for the end-to-end coordination of cross functional data collection and cleaning activities to ensure clinical study data deliverables are fit for purpose and align with the executed contract and sponsor expectations and ti[...]