- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Management (CQM), Inspection Readiness Lead (IRL) is responsible to support Clinical Inspection Readiness (IR) and pre-approval Inspection preparation ... governance, framework and culture of operational excellence. Metrics and Collaboration Opportunities: Support the clinical teams to generate metrics and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Management Plans (RMPs) (design, management , and maintenance) for global clinical trials.Provide day-to-day support to study teams and their line ... oversight tools, management , and maintenance), and provide day-to-day operational risk support to study teams and their line management to ensure prevention… more
- Merck & Co. (Rahway, NJ)
- …operations to achieve those objectives. -Under the guidance of the Regional Director, Clinical Quality Management (RCQM), and in collaboration with the ... Clinical Research Director(s), the Sr CCQM Lead establishes and/or - local clinical Quality Management System (CCQMs) aiming to achieve the organizational… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA ( Clinical Research Associate) and/or CRA Manager, acts as primary site contact and site manager-throughout all phases of a ... ensures continuity of site relationships through all-phases of the trial.Performs clinical study site management /monitoring activities in compliance with… more
- Novo Nordisk Inc. (WA)
- … support role and responsibilities Drives recruitment and retention strategies to support clinical trial sites to meet country enrollment and retention ... strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …document archive. Identify and resolve issues with the reconciliation. Knowledge Management : Support Department in codifying existing knowledge and best ... supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people...will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to applicable Daiichi Sankyo and regulatory requirements. Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management ... management expertise to project/study teams to optimize study-specific clinical trial processes.May participate in process improvement initiatives.Qualifications: Successful… more
- Merck & Co. (North Wales, PA)
- …Program Lead, you will collaborate with global, cross-functional team members including clinical directors and study managers to lead/ support - clinical trial ... activities.Job Responsibilities Responsible for the clinical /scientific execution of clinical protocol(s).Serves as the lead clinical scientist on the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Meets with commercial group regarding new indications for Life Cycle Management .Additional non-study related activities: Clinical Development involvement in due ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit ... surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit… more
- Merck & Co. (Rahway, NJ)
- …and SAP team members to further extend capabilities and functionalities on our existing Clinical Trial Supply Management (CTSM) solution in order to satisfy and ... and Distribution areas with a strong focus in Clinical Trial Supply Management (CTSM) is highly...Execution, Quality and- EHS. This role also provides close support to the Process Stewards, Product Owners and Business… more
- Merck & Co. (Rahway, NJ)
- …on clinical trial execution.Escalates site performance issues to CRM and Clinical Research Director CRD.People and Resource Management :Manage CRA - career ... critical to continuously develop key talents by providing training, support and mentoring to the CRAs and properly manage... ResearchMinimum of 3 years' experience as CRA monitoring clinical trialsLine management experience preferred or at… more
- Legend Biotech USA, Inc. (Fort Worth, TX)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Sr. Cell Therapy Clinical Educator - Mid South as part of the Commercial team based in the ... territory. Role Overview The Sr. Cell Therapy Clinical Educator are field based commercial personnel responsible for...advanced practice providers (APPs) and nurses involved in delivering care for patients treated with cell therapy. The individual… more
- Merck & Co. (Rahway, NJ)
- …and innovative solutions that enable new SAP capabilities and technologies. As the Clinical Manufacturing Delivery Lead for our Research & Development Division , you ... will be responsible for delivering SAP solutions to our Global Clinical Manufacturing user community. You will p articipate in interviews with our company's'… more
- Merck & Co. (Rahway, NJ)
- …of Contact (POC) for assigned protocols and link between Country Operations-and clinical trial team (CTT).Responsible for project management of the assigned ... scientific and clinical research knowledge is required.-Strong understanding of clinical trial planning, management and metrics is essential as-well as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and activities defined by leadership. Individual will provide strategic advice, teachings, and support related to risk management planning, risk management ... and risk management tools and resources.Responsibilities- Strategic Advice and Support to Global Product Teams: 1) Provides expert, strategic advice on the… more
- Merck & Co. (North Wales, PA)
- …processes related to the definition, use, maintenance and sharing of clinical data standards- Support department initiatives and participate in cross-functional ... by managementEducation Minimum Requirement: Bachelors degree with 1 year of clinical data management or standards experienceOrAssociates degree with 3… more
- Tris Pharma (Monmouth Junction, NJ)
- …salary commensurate with experience. The position is a core member of the Clinical Development management team responsible for developing and implementing, in ... and in respectful, open and honest communications to help support individual and team success.We have an immediate opening...alignment with corporate strategy, the clinical development plan for multiple, concurrent programs spanning all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking ... supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people...documents to the CRO and vendors as appropriate.- Provide clinical administrative support to the study teams.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Clinical Project Management experience required. Time spent directly in… more
