- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …industry experience in trial diversity and patient access and/or clinical operations project management (required) required- Demonstrated success in working ... around rare diseases and immune disorders.Summary The Head of Clinical Trial (CT) Diversity sits within Global... trials- Monitor data and regularly communicate findings to senior leadership to make recommendations for process improvements -… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …opportunities and potential mitigations and develops new forecasts as required Ensures that clinical trial budgets remain on track and aligned with global ... Continuously monitors and reports on status and expected outcomes Ensures all clinical trial -related SAP transactions are posted appropriately Manages and… 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 CRO and ... and immune disorders.Summary Assist in planning and execution of clinical studies, under the supervision of the Study Manager...other vendor performance against project goals and milestones to monitor and ensure compliance… more
- Merck & Co. (North Wales, PA)
- …or related field and at least 5 years SAS programming experience in a clinical trial environment orMS in Computer Science, Statistics, Applied Mathematics, Life ... position is a key collaborator with statistics and other project stakeholders in ensuring that project plans...at least 3 years SAS programming experience in a clinical trial environment. Required Skills: Effective interpersonal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… more
- Merck & Co. (North Wales, PA)
- …with a minimum of five (5) years SAS programming experience in a clinical trial environment.Required Experience and Skills: Experience with study data standards ... external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management, Clinical and other project stakeholders.- Primary Responsibilities:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigators is expected. The CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... Clinical Science function. He/she will be responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a proactive safety strategy for such candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with PSLs/GPTs on ... for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and suggest innovative approaches to improve compliances and processes.- Some knowledge of clinical trial methodologies. Travel Ability to travel up to 10% ... and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …methods to resolve clinical development problems Work with the larger Global Project Team to deliver excellent medical support for DCR-PHXC and other clinical ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating...to develop new medicines for patients. The Position As Senior Medical Director for the liver disease team, you… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure ... lifecycle of the actual product Responsible for all areas related to patient safety in clinical trials Act as member of the trial safety group for dose… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies Target Product Profile (TPP) Development Support: Provide support for clinical trial strategy, regulatory development, and the development of ... product potential Project Management and Coordination Support: Assist project management efforts to coordinate transition between clinical development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leadership on local and global project teams. This role will be a senior member of the Regulatory, Quality and Clinical Reporting (RQC) team, and will ... medicinal product dossiers (IMPD), investigational new drug applications (IND), clinical trial applications (CTA), marketing authorization applications (MAA),… more
- University of Pennsylvania (Philadelphia, PA)
- …wealth of health and wellness programs and resources, and much more. Posted Job Title Senior Clinical Trial Project Manager (Center for Cellular ... new technology/systems required to enhance clinical research operations. The Senior Clinical Trial Project Manager will independently manage multiple… more
- University of Pennsylvania (Philadelphia, PA)
- …technology/systems required to enhance clinical research operations. In this role, the Sr Clinical Trial Project Manager will independently manage ... of health and wellness programs and resources, and much more. Posted Job Title Sr . Clinical Trial Project Manager (Center for Cellular Immunotherapy) Job… more
- J&J Family of Companies (Titusville, NJ)
- …NA-US-New Jersey-Raritan **Organization** Janssen Pharmaceutica NV (7555) **Job Function** Clinical Trial Project Management **Req ID:** ... for humanity. Learn more at https://www.jnj.com/. **Position Summary:** The Sr . Manager, Trial Delivery Leader (TDL) is accountable for clinical trial … more
- J&J Family of Companies (Titusville, NJ)
- …+ Experience with the following functions: clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research ... Senior Trial Supply Lead - 2406187681W... specific distribution agreements + Member of appropriate GCDO clinical trial teams + Develop strong internal… more
- J&J Family of Companies (Titusville, NJ)
- …track record of exemplary work behaviors and substantial PM experience to join our Clinical Trial Project Management (CTPM) team as Accelerando Program Lead. ... Senior Manager, Accelerando Program Lead - 2406197406W **Description**...As the Accelerando Program Lead, you will apply your Project Management expertise and advanced leadership skills on top… more
- Sanofi Group (Bridgewater, NJ)
- …for all methodological and statistical aspects for safety data analyses around pooled clinical trial data of project (s). Act as statistical consultant ... and provide statistical scientific leadership for clinical trial safety data within a project . Accountable...in the safety monitoring team and with other statistics project leaders and in communicating with senior … more
