- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and updates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(SP&L) function with assigned tasks related to steady supply of Clinical Trial Materials (CTM).ResponsibilitiesLead the authoring, revising, and managing ... authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The candidate will… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The RoleThe Associate Director , External Data Quality Management, is a strategic leadership role within ... accountable for driving the strategy, quality, and integrity of external data across the clinical trial portfolio. This role serves as a Subject Matter Expert… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end ... data expertise to promote and implement best practices across the Clinical Trial lifecycle.- Applies GCP principles to ensure all laboratory data management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures. Clinical trial ... of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after… more
- Genmab (NJ)
- …of all aspects of clinical drug development, with particular emphasis on clinical trial design, trial execution, and strong knowledge about the ... feasibility and allocation process of a program and/or study.Must understand the Clinical Trial matrixed process from research through post-marketing Phase IV,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure successful implementation of the CDx and associated data collection. Oversees clinical trial sample testing activities and data capture to support CDx ... the Dx partner for CDx project contracts. Supports CDx analytical and clinical validation studies in collaboration with Dx-partner Provides scientific and technical… more
- Lilly (Indianapolis, IN)
- …to enable clinical development and speed medicines to patients. The Associate Director , CTF Product Owner in Trial Management Investigator-facing ... people around the world. Trial Management Systems as part of Clinical Trial Foundations (CTF), within Clinical Design, Delivery and Analytics (CDDA),… more
