- Eisai, Inc (Nutley, NJ)
- …Clinical Programming manages and oversees JReview and SAS program development for clinical data processing, data review reports and listings. This includes ... and end user support to other areas of Data Operations, Data Management, Clinical Safety Data Review and Clinical team. The Assoc. Director of Clinical … more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible ... for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the… more
- Merck & Co. (Rahway, NJ)
- …supply chain deliverables and prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders.--Works directly in ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...(GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company Research Laboratories… more
- Merck & Co. (Rahway, NJ)
- …chain deliverables and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders.--Responsible and ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...(GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company Research Laboratories… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for ... Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …providing the safety leadership and serving as the primary point of contact.- Review and analyze data from clinical trials, post-marketing and other relevant ... signals. Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy, expectedness and relatedness.- Lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of FIH, ... clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible...cross-functional, integrated study plan and create initial study budget. Review study feasibility assessments provided by the CRO(s), lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Job Summary: Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate ... Manager within Clinical Operations, in adherence to the protocol, Good ...post trial information on required public forums (eg.clinicaltrials.gov).Under supervision, review and document CRO-generated reports, such as site monitoring… more
- Merck & Co. (North Wales, PA)
- …projects as a manager of at least 5 statisticians.Serve as a reviewer for the cross-functional translational medicine document review committee.Support due ... is to provide statistical support for the pharmacology components of all clinical trials in our Company's Research Laboratories clinical development pipeline.… more
