- Option Care Health (Dublin, OH)
- …patients with acute and chronic conditions in all 50 states. Through our clinical leadership, expertise and national scale, Option Care Health is re-imagining the ... infusion care experience for patients, customers and employees. As a two-year recipient of the Gallup Exceptional Workplace Award, we recognize that part of being extraordinary is building a thriving workforce that is as diverse as the patients and communities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical ... Monitor. Represents Clinical Development on Study Team and collaborates as team...with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical… more
- Novo Nordisk Inc. (Los Angeles, CA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global ... Clinical Science function. He/she will be responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each… more
- Merck & Co. (Rahway, NJ)
- …site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.Actively develops and expands ... the territory for clinical research, finding and developing new-sites. Participates in internal meetings and workstreams as SME for monitoring processes… more
- Merck & Co. (North Wales, PA)
- …the delivery of our company's diverse development portfolio comprising over 200 clinical trials in compliance with global and local regulations. The Regional ... on a global basis. We are responsible for negotiating industry sponsored clinical trial agreements, confidentiality agreements, and other type of agreements related… more
- Merck & Co. (North Wales, PA)
- …relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections, Trial Data Integrations, ... trial participants, in the right way to enable the Clinical Research to analyze data for efficacy, dosing, safety...safety profiling and adverse events. The data collected from Clinical Trials are used to support drug applications and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Specialist, Clinical Operations Global Clinical Trial Operations (GCTO) is a global organization operating in over 50 ... the delivery of our company's diverse development portfolio comprising over 200 clinical trials in compliance with global and local regulations. The Regional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good ... Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; ... Represents clinical function at meetings with health authorities; Oversees management...and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product ... Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of...product lifecycle Independently leads activities without supervision for assigned clinical studies Lead activities under the direction of … more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Clinical Pathology Scientist (Principal Scientist) supports clinical teams in the use of pathology in clinical trials, ensuring timelines ... This position will work closely with the Head of Clinical Imaging and Pathology, Pathology Leads, and other ...Clinical Imaging and Pathology, Pathology Leads, and other Clinical Pathology and ImagingScientists to provide support internally and… more
- Merck & Co. (Rahway, NJ)
- …(Principal Scientist)has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our ... company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post ... registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials ... and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a subject… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall strategic ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the... Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered to time,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function on study ... of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of the drug.… more
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