- Merck & Co. (Rahway, NJ)
- …enhance standards and associated processes for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards ... existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Brief Description:The Clinical Development Lead , Oncology, BTC (Biliary Tract Cancer) ... and GEA (Gastroesophageal Adenocarcinoma) will lead the late-stage development and life-cycle management ...approvals. Clinical Trial Oversight: Oversee the execution of clinical trials, monitoring study progress, data quality,… more
- Nesco Resource (Pleasanton, CA)
- …candidate's location on the top of the resume.Basic Functions and General Scope:The Clinical Development Lead , Infection and Immunity, provides clinical ... and the design of performance verification and troubleshooting experiments. Reviews the data from these experiments from a clinical perspective.Develops product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical device, ... , is accountable for an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical...data sets and identifies any erroneous data . Lead Companion Diagnostics data management … more
- Merck & Co. (North Wales, PA)
- …activities.Job Responsibilities Responsible for the clinical /scientific execution of clinical protocol(s).Serves as the lead clinical scientist ... database set up) Lead medical monitoring team in review and interpretation of clinical data /medical protocol deviations in collaboration with the Clinical … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific ... guidance of more senior staff, may serve as the data management lead or perform...the development of, and ensures adherence to, our company's clinical data management procedures. Interacts… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical ... or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools is a plus preferred Daiichi… more
- Merck & Co. (North Wales, PA)
- …of one or more clinical trials in the lung cancer program. Assists the Lead Clinical Scientist and study team with the scientific conduct of clinical ... development of Protocol and related study materials (eg, ICF documents/amendments, data management deliverables).May interact with internal and external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (Rahway, NJ)
- …continuity of site relationships through all phases of the trial.Performs clinical study site management /monitoring activities in compliance with ICH-GCP, ... as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …monitoring plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems.Company Sponsored ... tracking of milestones as per contract). Ensure the global clinical operations systems for management of company...activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data , and quality.Establish… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …working on projects/studies and/or initiatives. Lead and manage the standardized Data Management Process and Procedures for consistency across programs and ... and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs… more
- Merck & Co. (North Wales, PA)
- …the position:Serve as a statistical representative and core member in the Risk Management Safety Teams.- Lead and provide statistical support for related ... and data processing software eg SAS and/or R.-Good project management skills. --Good understanding of worldwide regulatory requirements and clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director, Clinical Safety, will be a product safety lead or part of a ... , and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management , important… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the ... recommends, and implements new technologies, as needed and supports Supply Chain Management with technical issues post first CPV.Responsibilities- Lead and… more
- Option Care Health (Bannockburn, IL)
- …and/or support business growth based upon evidence supported on OCH patient population data . The VP builds a Clinical Effectiveness team with focus on ... external data and presents on opportunities for quality improvement, clinical service enhancements, clinical service offering expansion and other mechanisms… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The global head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations, Data Management , Scientific Operations etc) and ... the outsourcing strategy for the regulated bioanalytical sciences and will lead regulatory interactions related to bioanalysis and evaluates/sets the strategy for… more
- Eisai, Inc (Nutley, NJ)
- …to both clinical trial setting and observational studies.Serve as the lead statistician on project teams, offer statistical insights into clinical ... responsibilities.Ensures the timely and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data , patient… more
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