- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position We are looking to hire a Clinical Project Manager (CPM). This is a unique opportunity to work in a ... in the pharmaceutical industry Minimum 2 years of experience as a Clinical Trial/ Project Manager Experience with global clinical trial operations,… more
- Merck & Co. (Rahway, NJ)
- …on the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents. Partners with Study Manager on study ... writing, and presentation skills.Education/ExperienceBachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical… more
- Merck & Co. (Rahway, NJ)
- …the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... : Education Minimum Requirement: Bachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or-medical field experienceOR… more
- Merck & Co. (Rahway, NJ)
- …PowerPoint, Word, Outlook, etc.)Education/ExperienceBachelor's Degree +2 years of pharmaceutical, clinical drug development, project management, and/or medical ... field experienceOR Master's Degree +1 year of pharmaceutical, clinical drug development, project management, and/or medical field experienceDegree in life… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Data Standards is responsible for the development and ... people at different levels are also some of the requirements of this role. The Manager , Clinical Data Standards should be a subject matter expert in clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops ... and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study...with Data Management, establish the EDC strategy at the project and/or study level. Proactively identifies and manages risks… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensure its quality and integrity- Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. ... Responsibilities include: review and agree on vendor project timelines and resource planning, work in tandem with...and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager , Bio Sample Operations is responsible for supporting the oversight of the ... of Bio samples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but...limited to conduct of gap impact assessment and developing project scope and project plans. Work cross-functionally… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety,… 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 ... for the financial management and budget development of North America Clinical Operations (NACO). Responsible for driving financial oversight across trial portfolios… more
- Aequor (New York, NY)
- …from over 100&plus markets. The candidate will also serve as the core project manager for the Pneumococcal GASP team. Collaborates with cross-functional team ... and tools in health services research is required, eg, literature review, clinical data interpretation and claim data analysis Knowledge of data science desirable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Manager as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThe CAR-T Operations Manager is an exempt level position working within Technical...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.Key… 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 ... difference? The Position The HEOR Strategy and Evidence Synthesis Manager will be part of the HEOR Evidence Synthesis...sub-team. The HEOR-ESS sub-team is part of a larger Clinical Data Science and Evidence (CDSE) team which sits… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to… 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 ... May participate in FDA submission planning meetings to ensure clear communication of the project plan, actions items, risks, and decisions to the team as it relates… more
- Genmab (Plainsboro, NJ)
- …Vendor Management, will play a pivotal role in managing the relationships with the clinical vendors as well as coordinate and manage outsourcing of new trials. The ... in - and is not limited to - the following areas.Key Account Manager :Coordinate Sourcing for New Trials: Responsible for coordinating sourcing for new trials to… more
- Novo Nordisk (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position We are looking to hire a Clinical Project Manager (CPM). This is a unique opportunity to work in a ... in the pharmaceutical industry + Minimum 2 years of experience as a Clinical Trial/ Project Manager + Experience with global clinical trial operations,… more
- Merck (Rahway, NJ)
- …Inventory Management Section of the GCS Planning organization. Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) ... Clinical Finished Goods (CFGs) + Analyzes and anticipates project risks as they relate to clinical ...anticipates project risks as they relate to clinical supply chain deliverables and prepares, analyzes, and/or develops… more
