- Eisai, Inc (Nutley, NJ)
- …activities (feasibility, start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support , creates, ... and communicates clinical study timelines. Gathers input from cross- functional teams and...team produce deliverables on schedule. Ensures consistency of clinical study and processes across clinical… more
- Merck & Co. (Rahway, NJ)
- …with global, cross-functional team members including clinical directors and study managers to lead /support clinical trial scientific activities in ... strategy and execution of Phase 1-4 clinical studies . Under the direction of the Program Lead...trial team .Collaborates with the Medical Writer on clinical /scientific and regulatory documents. Partners with Study … more
- Merck & Co. (Rahway, NJ)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint ... and supervise the activities of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional group of experts in… more
- Merck & Co. (Rahway, NJ)
- …-functional team members including clinical directors and study managers to lead /support clinical -trial scientific activities.Job Responsibilities ... strategy and execution of Phase 1-4 clinical studies . Under the direction of the Program Lead...trial team .Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... with Clinical Scientists (CS)Interpretation and presentation of clinical study (ies) data to internal and external...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …environment are some of the requirements of this role. Leading-edge skills in clinical data standards, expertise in Study Data Tabulation Model (SDTM), excellent ... areas centered around rare diseases and immune disorders. Summary The Manager, Clinical Data Standards is responsible for the development and sustainability of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major ... updates; Responsible for valid clinical interpretation of study results as Clinical Study ...KOLs or major institution, eg NCI.Scientific, Program related: Integrated Study Team (IST) representative: Creates early development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product(s) or clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and build and review Statistical Analysis Plans (SAPs) and ... management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and cross-functional team in...of minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent… more
- Merck & Co. (Rahway, NJ)
- …biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, Statistical Programming, ... assigned to a development project as neededLead biostatistics in early or late clinical development planning to ensure that study designs are consistent with… more
- Merck & Co. (Rahway, NJ)
- …and execution of scientific & medical affairs plans for Ophthalmology). They build and lead a team of TA dedicated global and regional directors and associate ... real-world evidence data generation and coordinates local data generation studies with V&I Outcomes ResearchSupports the Investigator-Initiated Study … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... Clinical Scientists (CS)- Interpretation and presentation of clinical study (ies) data to internal and external...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... with Clinical Scientists (CS)Interpretation and presentation of clinical study (ies) data to internal and external...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; works closely with ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... and leadership abilities. Ability to present in a group environment.--Ability to lead a team .Ability to be flexible, multi-task and work independently.--Basic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex… more
- Merck & Co. (Rahway, NJ)
- …strategic decisions, improve planning/execution, and monitor performance across our portfolio, studies & processes within Global Clinical Trial Operations ... Business Analyst, within Metrics, Analytics & Performance (MAP) will lead activities related to the development, delivery, & maintenance...Experience and Skills:At least 8 years working on a clinical trial team or has worked in… more
- Merck & Co. (Rahway, NJ)
- …project activities at external manufacturing sitesFacilitate manufacturing, packaging and release of clinical supplies for clinical studies , assist in scale ... Job DescriptionOur company's Pharmaceutical Sciences and Clinical Supplies (PSCS) organization translates molecules to medicines, working from the discovery… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight.Manage and/ or guide the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs, external publications, and ... CDx/Translational Oncology/Precision Medicine/ RD-DLTb. External Alliance Committee. b. Quality leadership team c. Develop/ chair or co- lead quality council as… more
