- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and ... 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … development experience in the pharmaceutical industry Minimum 2 years of experience as a Clinical Trial /Project Manager Experience with global clinical ... The CPM will be responsible for all aspects of clinical trial management aimed at treating a...You will be responsible for the successful execution of clinical trials from protocol finalization through closeout.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical trial outsourcing, health sciences or related field ( clinical trials ) required.Advanced WORD and Excel skills preferred.Excellent time management ... the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional...skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight of the end-to-end lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but not limited to ... knowledge of CLIA/CAP regulations and GLP guidelines preferredBasic knowledge of clinical trial design; understanding of the overall drug development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials , Managed Access programs and Collaborative Research to the highest ... to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials , Managed Access programs and Collaborative Research to the highest… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …NOTE: This Project Lead Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling the on-time delivery of ... clinical supplies across the DSI portfolio. This role as...to CSO Supply Planning as requested.Responsible for updating relevant Trial Master Files (TMF) with CSO-related documentsSupports the CSO… more
- Eisai, Inc (Nutley, NJ)
- …includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness ... profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with R&D IT...validation or user acceptance testing, and integrations with other clinical applications through change management. Maintains the eTMF system… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides US market access input to Global and US stakeholders to inform clinical trial programs, guide evidence generation development, payer value stories, and ... of cell therapy reimbursement. Shape the payer value story, supported by credible clinical , health economics and quality of life messages as the market and the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal relationships may include MA management, MA project management, Medical Communications, Clinical Trial Management, Clinical Development and Outcomes ... interests on cross-functional teams including, Field Medical Affairs, Medical Operations, Clinical Trial Management, HEOR, Market Access, Marketing and other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …scenarios and strategy for all pipeline products starting in Phase II clinical trials . Generates insights to support G3 decision-making Assesses investments ... in payer contracts and develops patient copay program strategy in collaboration with marketing colleagues. Provides strategic guidance on how to balance these investments across the franchise Supports contracting strategy and roadmap development for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …may include Medical Affairs, Regulatory Affairs, Marketing, Learning & Development, Clinical Trial Management, and Clinical Development. Essential ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and will also have a reporting relationship with a manager /preceptor in the respective functional areas during their rotations.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …inspection/release of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP ... handling tasks in a backup role, as needed. Updates supervisor/ manager of work status or problems with recommendations for...of 2 years of experience with quality support in clinical manufacture or NPI is preferred.Experience in clinical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Product QC Testing, related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key ... the safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager when data discrepancies are identified. Job duties performed may… more
- Axelon Services Corporation (Princeton, NJ)
- …strategies within a specific therapeutic area(s) and is accountable to support clinical trial vendor partnerships across select or multiple service categories ... of clinical trial activities in R&D. Key Responsibilities: - Drive outsourcing activities by interfacing with operational teams, support groups and service… 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
- Astellas Pharma (New York, NY)
- …support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and ... sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures...Trials may include both early and late phase clinical trials . + Develops meaningful site relationships… more
- The Mount Sinai Health System (New York, NY)
- …collaboration with the MM Medical Director, the Associate Director, and the clinical trials investigators; this candidate is responsible for the implementation ... and conduct of clinical trials with investigational anti-cancer agents at...attending physicians to identify and recruit patients eligible for clinical trial . + Establishes and maintains database… more
- The Mount Sinai Health System (New York, NY)
- …the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials . 6. Obtains informed consent under supervision of the ... Principal Investigator, Clinical Research Manager , or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects, and for studies… more
