- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and global Health Authorities, as well as contract research organization ( CRO ) programmers and statisticians. Additionally, this position works under minimal ... in the design of clinical studies from preclinical through Phase 3 and 4. - CRO / Vendor Oversight: Participates in drafting request for proposal for CRO … 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
- System One (Basking Ridge, NJ)
- …professional pharmaceutical industry experience, or other related healthcare experience (ie, CRO ) with experience related to study activities assigned related to ... post-marketed drug development in either the pharmaceutical industry or within CRO . Education: Bachelor's Degree Related Sciences required System One, and its… more
- Actalent (Morristown, NJ)
- …+ At least 7 years of medical writing experience in the biopharmaceutical/ CRO industry. + Experience leading submissions for marketing approval. + Proficiency in ... + Experience with all phases of clinical trials, I-IV. + Experience in both CRO and sponsor environments. + Focus on oncology and immunology therapeutic areas. Work… more