- 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)
- …with the planning & successful delivery of studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North ... in the pharmaceutical industry (Pharma/Biotech/CRO) Previous experience leading cross-function clinical trial operations teams preferred Expert in ICH-GCP… more
- Merck & Co. (Rahway, NJ)
- …and sustained. The Sr CCQM Lead supports large to medium size country/cluster clinical trial operations to achieve those objectives. -Under the guidance of ... in a functional and/or line management position.Deep knowledge and understanding of Clinical Trial processes, GCP and applicable clinical research-related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… 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
- Merck & Co. (North Wales, PA)
- … trials.Job ResponsibilitiesResponsible for the operational planning, feasibility, and execution of a clinical trial .May serve as the clinical trial ... PowerPoint, Word, Outlook, etc.)Education/ExperienceBachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical… more
- Merck & Co. (North Wales, PA)
- …preparation of status update reports, study closeout activities).- May serve as the clinical trial team (CTT) lead. -Leads team for timeline management, risk ... Job DescriptionPosition Description: Senior Study Manager - Cardiometabolic Our Clinical...site selection criteria with cross-functional team.-Works closely with Global Trial Optimization (GTO) to: develop patient recruitment and retention… more
- Merck & Co. (North Wales, PA)
- …of the study protocol.Prepares oral presentations and written reports to effectively communicate clinical trial results to the project . team, company ... research activities for innovative statistical methods and applications in clinical trial development.Education Minimum Requirement: PhD in… 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
- Merck & Co. (Rahway, NJ)
- …pharmacokinetic, exposure-response, quantitative system pharmacology, and other model-based analyses.-Perform clinical trial simulations to inform dose selection ... the role of- Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy:...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… 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
- 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)
- …investigators is expectedThe CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... Global Clinical Science functionHe/she will be responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for… 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
- Taiho Oncology (New York, NY)
- …SLs, HCPs, and institutions in geography to be covered is preferred. Clinical trial development experience is preferred. Knowledge of treatment guidelines, ... and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo,… more
- Mindlance (Atlanta, GA)
- …mathematics or related field * Extensive experience of statistics in a clinical trial environment. Evidence of providing expert statistical input in ... and regulatory knowledge to the department. Acts as the senior reviewer on simple or moderately complex projects, and...on complex or highly complex studies. Acts as a project manager, overseeing the statistical and programming aspects of… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …in conjunction with project team members, regulatory affairs, and senior managementProvide clinical /scientific input during the development, execution, and ... completion of clinical trialsInterpret clinical trial data and prepare reports, regulatory submissions, and publications based on the resultsMonitor … more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …Medical Affairs training and excellence as well as excellent organizational and project management skills. The position will deliver by building strong relationships ... assigned TA. Maintain accurate and updated training content by incorporating new trial data and disease state information, etc. for assigned TA.Collaborate with USMA… more
