- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project manager for other activities involving assigned product(s) or clinical studies, as needed.QualificationsSuccessful candidates will be able to meet the ... position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project manager for other activities involving assigned product(s) or clinical studies, as needed.QualificationsSuccessful candidates will be able to meet the ... position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with ... critical support to the CSL and Medical Monitor in the execution of Clinical Development functions. Responsibilities: Study Strategy: Drafts development plan… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the ... application of external data vendor access standards across DS clinical programs. Participate in the development of...across DS clinical programs. Participate in the development of and ensure compliance to Standard Operating Procedures… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Plans in close communication with CSO project Management Lead.Responsible for the Clinical Label Development process which includes creation of master label ... 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development . preferredOncology experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …skills and communicate progress and risks toward the timely testing of biomarkers in clinical development programs. The role is expected to work in close ... of biomarker test results, and regulatory submission activities for Daiichi Sankyo clinical development .Contributes on biomarker related sections of clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution of master agreements on a timely basis. Management and oversight of Clinical Development contracting process, review and approval in accordance with ... to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services...able to work in complex categories. Assist in the development and implementation of new processes, procedures and/or systems… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …field of oncology, with a deep understanding of the drug discovery and development process, clinical trials, and regulatory requirements. TravelAbility to travel ... areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... driving strategy development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight over the site Quality Control laboratories responsible for testing of pre- clinical , clinical , and commercial stage CAR-T cellular therapy products. ... providing quality oversight for site Quality Control laboratories responsible for testing pre- clinical and clinical and commercial stage CAR-T cellular therapy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …records, forms, and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel, provide ... directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be… more
- J&J Family of Companies (Raritan, NJ)
- …at https://www.jnj.com/innovative-medicine **We are searching for the best talent for Analyst II, Clinical Data Manager to be located in Raritan, NJ, Titusville, ... Spring House, PA, Horsham, PA.** **Purpose:** The Analyst II Clinical Data Manager is a professional individual...industry or related field or industry. + Experience in clinical drug development within the pharmaceutical industry… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with ... support to the CSL and Medical Monitor in the execution of Clinical Development functions. **Responsibilities:** + **Study Strategy:** Drafts development… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key ... abroad, governmental, academic, community and industry organizations. The Senior Clinical Study Manager role is primarily a...level time, cost and quality deliverables. + Lead the development of the clinical study plan including… more
- Fresenius Medical Center (Kenvil, NJ)
- **About this role:** As a Clinical Manager with Fresenius Medical Care, you will ensure that quality patient care is delivered while maintaining clinical ... will cover onboarding, essential functions, leading your business, and advanced leadership. As a Clinical Manager , you may advance your career into an Area Team… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … team, provides input into product development strategies and/or research or clinical development plans for assigned products / projects. + May author the ... and execution. You will champion model-based drug discovery and development and serve as a clinical pharmacology...discovery and development and serve as a clinical pharmacology specialist to cross-functional partners. We have the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …project manager for other activities involving assigned product(s) or clinical studies, as needed. **Qualifications** Successful candidates will be able to meet ... This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …project manager for other activities involving assigned product(s) or clinical studies, as needed. **Qualifications** Successful candidates will be able to meet ... This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product… more
