- Merck & Co. (North Wales, PA)
- …responsibilities include, but are not limited to:Collaborate closely with biomarker scientists and project teams to plan clinical trial biomarker set-up ... realm)Preferred Experience and Skills:Drug discovery experience, including familiarity with clinical trial execution in Oncology studiesBiomarker assay… more
- 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
- 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
- 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)
- …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
- 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)
- …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)
- …reports (CSR) Investigator brochures (IB) Informed consent and assent forms Lay summaries of clinical trial results Clinical evaluation plans (CEP) and ... Are you ready to make a difference?The Position The Senior Medical Writer works closely with cross-functional project...to detail to ensure the accuracy and consistency of clinical trial documents A strong foundation in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trials from the clinical science perspective, and ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical ... diseases and immune disorders. Summary This position is a Clinical Science lead position and will lead a group...position may be at the executive director level or senior director level, depending on the scope and size… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Director and Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations ... other stakeholders. The Medical Director will also assist the Senior Medical Director in the development and execution of...Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources… 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
- 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...make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific… 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)
- …Janssen Research & Development, LLC (6084) **Relocation Eligible:** No **Job Function** Clinical Trial Project Management **Req ID:** 2406196904W ... Sr . Program Analyst, Clinical Operations -...success and execution of assigned/delegated tasks to support global clinical trial operations in the management of… more
