- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …plan and create initial study budget. Review study feasibility assessments provided by the CRO (s), lead the CRO selection process and provide input into ARO ... + Validate the study implementation plan provided by the CRO through to study close out and CSR writing....kick-off meetings and study team meetings. + Oversee the CRO and provide timely input to ensure that the… more
- Hunterdon Health Care System (Flemington, NJ)
- …procedures performed in the Cath Lab. 3. Function as hemodynamic monitor and control room operator during procedures; provides accurate recordkeeping of ... 6. Maintain record of images, reports, equipment maintenance, and inventory control . Qualifications Minimum Education: Required: ? High School Diploma or Equivalent… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …program and for direct reports. + Perform & document the oversight of CRO data management activities for assigned studies: + Ensure the design, implementation and ... checks are performed according to SOPs and WIs. + Identify data quality, CRO performance, documentation, process execution gaps and is accountable for resolution. +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …teams and ensuring execution against the risk management plan. + Oversee CRO partnership related to delivery of outsourced services, including ensuring that CTM ... staff provide an appropriate and documented level of oversight for site/ CRO /vendor services + Actively participate in appropriate governance meetings and acts as… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Represents Data Management in governance bodies internally and externally with CRO partners and stakeholders. + Liaises with other function heads to ensure ... provide strategic thinking for outsourcing strategy. As a member of the CRO governance committee, provides strategic leadership in Data Management related topics and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with some supervision. This position also guides contract research organization ( CRO ) programmers and statisticians in preparing analysis files and performing ... can fulfill regulatory requirements and deliver the pre-specified product profile. + CRO / Vendor Oversight: Review CRO /vendor proposal and budget. Establishes… more
- Taiho Oncology (Princeton, NJ)
- …Monitors Trial Master File related KPIs and performs quality review of the eTMF (per CRO oversight plan) while collaborating with internal and CRO study teams to ... Monitoring Visit Reports (SEV, SIV, IMV, COV) from the CRO to ensure that sites are in compliance with...support or site management experience in the pharmaceutical, biotechnology, CRO and/or healthcare industry. + Experience and knowledge of… more
- Bristol Myers Squibb (Princeton, NJ)
- …Skills, Abilities:** + Demonstrated experience of working directly at or with an Imaging Core Lab/ CRO a plus + Minimum of 5-6 years pharmaceutical or CRO project ... minimum of 3 years in imaging operations (imaging core lab and/or Imaging CRO ), preferred + Demonstrated experience managing 3rd party vendor + Demonstrated ability… more
- Bristol Myers Squibb (Princeton, NJ)
- …of data management, from planning and coordination to execution and quality control . The successful candidate will be responsible for managing relationships with ... of data management personnel and activities of CROs and vendors. + Ensure CRO adherence to project timelines, from study startup to study closeout, while maintaining… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …experts and external KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes effective communication between ... CRO / vendors / ARO + Additional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL and prepares material… more