- 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
- Merck & Co. (North Wales, PA)
- …execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical monitoring ... and prioritization skillsStrong analytical skills with the ability to interpret clinical trial data and synthesize conclusionsInteract with key stakeholders… more
- Merck & Co. (Rahway, NJ)
- …for the company's internal clinical trial portfolio.Partner with Clinical Research Organization (CRO) Senior , Regional and local team to ensure ... safe, effective, innovative medicine.The position manages all aspects of clinical trial operations in a country and... Quality Managers (CQMs).Engage with Functional Service Provider (FSP) Senior , Regional and local team to ensure adequate 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …into the Global Clinical Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered to time, quality, and cost. ... scope/portfolio.Close collaboration with Asset and Portfolio Management (APM), GCO Clinical Trial Business Operations (CTBO), and GCO...ideally including time in role such as a Global Project Leader at Sr . Director level or… 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
- Merck & Co. (Rahway, NJ)
- …in meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies.Ensures the statistical designs ... Involved in research activities for innovative statistical methods and applications in clinical trial development. Education and Minimum Requirement: PhD or… 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
- Merck & Co. (Rahway, NJ)
- …Lead research activities for innovative statistical methods and applications in clinical trial development. Collaborates in publication of research results ... project as neededLead biostatistics in early or late clinical development planning to ensure that study designs are...SAS and/or R.-Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to… 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. (Rahway, NJ)
- …execute and development of methods for release, characterization, and stability testing of clinical trial material and in support of product and process ... department of our Research & Development Division is seeking applicants for a Senior Scientist position available at our research facility. The Senior Scientist… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program management, ... of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical … 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
- Aequor (Piscataway, NJ)
- …The S/MMC is expected to: Possess ability to understand and interpret clinical trial data, the literature and associated therapeutic conditions Coordinates ... Job Title: Manager/ Sr . Manager Medical Communications Hybrid schedule: West Chester.PA...Ability to establish and leverage relationships with external experts, clinical trial investigators, journal editors, and congress… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... regions/markets Ensure compliance with legal requirements- Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, and… more
- Merck & Co. (Rahway, NJ)
- …closely with US RDMAs and others in GMSA TAs, US Health Systems, Global Clinical Development (GCD), Global Clinical Trial Operations (GCTO), Global Medical ... FM teams.Responsibilities and Primary ActivitiesLeadership and ManagementServes as a senior leader in the USMA organization, broadly influencing medical activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management ... with the business strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business...strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study findings through presentations and/or publications in peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize ... analysis of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries… more
- George Washington University (Washington, DC)
- …of Public Health at the George Washington University is seeking a Senior Biostatistician to assist the department in conducting an NIH-funded prospective multi-site ... longitudinal cohort study, the DC Cohort. This study captures clinical information on persons with HIV receiving outpatient HIV care in Washington, DC, at 14 … more
