- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager 's (CRMs) ... Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned studies:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a project manager for other activities involving assigned product(s) or clinical studies, as needed Qualifications: Successful candidates will be able to meet ... supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety...in one or more focus areas - Supports Data Monitoring Committees (DMCs) and due diligence activities for assigned… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a ... of checks, such as data flow and derivations monitoring , for clinical data repository and triage… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities. 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
- Novo Nordisk Inc. (Atlanta, GA)
- …tools; executes activities relevant to all visit types (Site Selection, Site Initiation, Monitoring , and Closure) for assigned sites and clinical trials Verifies ... at clinical trial sites in accordance with the protocol, Monitoring Plan and other associated trial documents Complies with relevant training requirements.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development of charters for study committees (eg, Executive Committee). Provides input to Clinical Operations on monitoring plan (eg data fields to be SDV'd) ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… 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 ... The Position Takes ownership to deliver upon near-term North America Clinical Development (NACD) goals, including successful delivery of studies within the… more
- Merck & Co. (Rahway, NJ)
- …case report form (CRF) data, lab data, other external data, biomarker data, and clinical outcomes assessments.2. Serves as project manager of all clinical ... Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal ... evaluate biomarkers across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development, this individual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary Position supports safety monitoring and risk management activities, provides insights on current clinical ... single event level AE causality assessment. This position requires manager review and gains industry knowledge through multiple opportunities. ResponsibilitiesSafety… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for ... global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's publication policies and procedures and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other… more
- Catalent (San Diego, CA)
- …, Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a ... Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of...manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses ... in a quick turnaround, support ad-hoc and exploratory analysis requested by clinical team, provide programming supports in agency response or potential Advisory… more
- Merck & Co. (Ames, IA)
- …and USDA regulatory policies.- The position will require developing trial protocols, monitoring and summarizing clinical and marketing support trials specific to ... Ruminant animal health.- Position will be required to maintain contact with key industry professionals to include academic, veterinary related individuals or groups.- Additional duties will include attending and presenting in prominent industry scientific… 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 ... Exchange Agreement (SDEA) related matters. To contribute and support quality monitoring activities related to Adverse Event reporting and quality tasks performed… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the successful execution of brand-level marketing ... by consulting with executional teams to drive optimal performance Performance Monitoring : Report on key marketing performance indicators (KPIs) to measure the… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager of Supply Chain and Logistics plays a crucial role in supporting ... both the commercial and clinical supply chains at Insmed. The primary focus is...for partners, ensuring on time, compliant, day-to-day shipment management, monitoring vendor performance through KPIs, and tracking budgets. The… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Manager /Sr. Manager , External Manufacture as part of the Technical Development ... position will be responsible for managing the technical transfer and clinical /commercial manufacture of cell therapy products in our external manufacture… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other… more
