- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …on Project Teams. **Responsibilities:** + Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, ... data quality listings, SAP, Data Management plan; Reviews patient population and...KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes… more
- IQVIA (Parsippany, NJ)
- …willingness to learn new systems. + Monitoring experience or relevant experience in data management or central monitoring. + Proficient in speaking and writing ... Trial Team to resolve CAPAs timely. + Contribute to data collection for site selection and participate in feasibility...management experience in the pharmaceutical industry or large CRO . + Strong working knowledge of ICH-GCP, local laws,… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …performance. + Partner with senior leadership in key R&D functions (Clinical Management , Data Management , Global Pharmacovigilance, Regulatory Affairs, Asset ... key functional partners (Clinical Management , Regulatory Affairs, Global Quality, Data Management , Global Pharmacovigilance etc.) + Provide oversight of… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management , and medical writing. + Complete ... and clinical study and safety documents. + Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management , and medical writing. + Experience with ... and clinical study and safety documents. + Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Research Organization ( CRO ) Medical Monitor (MM): + Provides oversight to the CRO MM for clinical data review activities + May support addressing eligibility ... oversight for one or more clinical trials + Matrix management responsibilities across the internal and external network +...and CCG (CRF Completion Guidelines) review + Conducts clinical data review per Integrated Data Review Plan… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** Under the direction of the Director/Associate Director of Clinical Management , the Senior Clinical Study Manager is responsible for the oversight and ... management of Otsuka clinical studies, including coordination with other...forecast to the Director/Associate Director.** **Establish communication flow with CRO and investigative sites to maximize compliance with study… more
- PsychoGenics (Paramus, NJ)
- Director, EEG **PsychoGenics** is a preclinical CRO with expertise in central nervous system (CNS) and orphan disorders. Our mission is to provide the best validated ... team, help design and develop study plans, and oversee data collection, data analyses, and data...their careers. + In coordination with project leaders and management , design and develop experiments to analyze EEG pattern… more
- Bausch Health (Madison, NJ)
- …AI-driven marketing innovations, and personalization strategies. + Develop a data -driven customer journey framework to enhance user experience, reduce friction, ... insights into competitor messaging, ad spend, and campaign effectiveness, making data -driven recommendations for Solta's marketing strategy. + Collaborate with brand… more
- Taiho Oncology (Princeton, NJ)
- …of scientific and regulatory documents. The Associate Director of Biostatistics will have CRO oversight, management of statistical projects, and the ability to ... TFLs for the clinical trials + Analyze and help interpret clinical data + Create/author statistical sections of scientific and/or regulatory documents + Manage… more