- Daiichi Sankyo, Inc. (Bernards, NJ)
- …literature review and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or similar environment (eg, CRO) requiredOncology, immunology, or complex disease clinical trial experience preferredMust have a strong understanding and ... around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical...MedDRA, and WHO not DD is requiredWorking knowledge of Clinical trial data systems and/or EDC coding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Develop and continue to refine a financial model for all phases of clinical trials . Research and investigate key parameters through quantitative analyses of ... - Manage and is accountable for the development of Clinical Project Budget templates in support of early phase...Budget templates in support of early phase to late-stage clinical studies. Accountable for the control and reporting of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to support drug development processes and global submissions as required for clinical trials . These include developing and validating SAS programs for ... centered around rare diseases and immune disorders. Summary The Manager , Data Programmer is a member of the Biostatistics... clinical trials . This position will work closely… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology, with a deep understanding of the drug discovery and development process, clinical trials , and regulatory requirements. TravelAbility to travel up to 5% ... areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for regulatory compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in Raritan, NJ. Role… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and ultimately our ability to deliver live changing therapeutics to those in need. Clinical Trials Manager , Clinical Operations - Oncology (CTM). ... is responsible for the execution of all Phase 1-4 clinical trials , across all therapeutic areas, around...Research, Medical Affairs and Development functions, ensures that all clinical trial activities are performed in accordance… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …able to adjust workload based upon changing priorities + Meets all requirements for Clinical Trial Manager (CTM) position with demonstrable proficiency. The ... is responsible for the execution of all Phase 1-4 clinical trials , across all therapeutic areas, around...Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance… more
- J&J Family of Companies (Raritan, NJ)
- … Clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols is preferred. + Experience in clinical ... Johnson & Johnson is currently seeking an Analyst II, Clinical Data Manager . This position can be...Knowledge of applicable international guidelines regarding data management of clinical trials is preferred. + Knowledge of… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The **Senior Manager Clinical Study Lead** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned ... large and/or complex clinical trials from study design, through execution,...maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial… more
- IQVIA (Boonton, NJ)
- …obtained through advanced education combined with experience. * Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in ... Oncology is preferred Job Overview Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Manager Clinical Statistician Date: Jan 16, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 58355 **Who ... and new people to make a difference with. **The opportunity** The Senior Manager Clinical Statistician is a skilled statistician with training and experience… more
- Deloitte (Morristown, NJ)
- …Experience in clinical analytics + Experience with solutions for data-driven trials and clinical development insights, eg, site burden, patient burden, study ... connections that empower a digitally enabled, equitable future of health As a Manager you will lead and deliver small engagements, or components of large, complex… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …review and creates reference list for study. + Study Planning: Contributes to clinical trial planning including identification of potential risks to study ... immune disorders. **Summary** Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Lead Clinical Scientist; Member of the Clinical Study Team and Global Clinical SubTeam + Line Manager for CS team and serves as key functional advisor ... The Director Clinical Sciences, Hematology, leads in the development, evaluation,...supporting literature + Authors and/or reviews documents related to trials , such as medical monitoring plans, SAPs, informed consents… more
- J&J Family of Companies (Raritan, NJ)
- …and close-out activities. The Associate, Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL ... the Sponsor and the Investigational Site. An Associate, Site Manager is assigned to trial sites to...sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures… more
- IQVIA (Parsippany, NJ)
- **Job Overview** Join our team as a Clinical Research Site Manager , where you'll play a crucial role in ensuring our study sites operate seamlessly and adhere to ... selection, initiation, monitoring, and close-out visits in line with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. +… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …timelines. This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical ... technical and operational statistical activities for a group of clinical trials . Directs internal and external teams...analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring. + Uses a variety… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to support drug development processes and global submissions as required for clinical trials . These include developing and validating SAS programs for ... centered around rare diseases and immune disorders. **Summary** The Manager , Data Programmer is a member of the Biostatistics... clinical trials . This position will work closely… more
