- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal stakeholders, advocate for the needs of diverse patient populations involved in clinical trials Analyze trial participant demographics and outcomes ... (CRE) strategy integrating diversity and health equity systematically in clinical trial planning and execution. This role...to trial design, planning & conduct of clinical trials Highly motivated self-starter with a… more
- Merck & Co. (Rahway, NJ)
- …clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... and prioritization skillsAdvanced analytical skills with the ability to interpret clinical trial data andsynthesize conclusionsInteract with key stakeholders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …NOTE: This Project Lead Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling the on-time delivery of ... clinical supplies across the DSI portfolio. This role as...to CSO Supply Planning as requested.Responsible for updating relevant Trial Master Files (TMF) with CSO-related documentsSupports the CSO… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensures quality delivery of all 3rd party data from diverse external providers for clinical trials , companion diagnostics trials , clinical development, ... and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... clinical trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the end-to-end lifecycle of Bio samples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but not limited to ... knowledge of CLIA/CAP regulations and GLP guidelines preferredBasic knowledge of clinical trial design; understanding of the overall drug development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology, with a deep understanding of the drug discovery and development process, clinical trials , and regulatory requirements. TravelAbility to travel up to 5% ... areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing,… more
- Merck & Co. (Rahway, NJ)
- …and posters/oral presentations that report results from our company's General Medicine clinical trial program, as well as select early-stage development projects ... Skills Strong writing skills and competence in biomedical research General Medicine clinical trial publications experience Understanding of clinical research… more
- Merck & Co. (North Wales, PA)
- …approval to facilitate initial approval by regulatory agencies for conduct of clinical trials .Participates in regulatory due diligence activities for licensing ... point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops worldwide product regulatory strategy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and suggest innovative approaches to improve compliances and processes.Some knowledge of clinical trial methodologies. Travel:Ability to travel up to 10% Daiichi ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to… more
