- Merck & Co. (Rahway, NJ)
- …role is accountable for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country regulations, ... Clinical Research, the individual is responsible to-manage/oversee a team of CTCs( Clinical Trial Coordinator).As line manager the role is critical to… 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, ... dynamic and growing Medical Affairs Department. Position Summary: The Senior Medical Science Liaison ( Sr . MSL) is...Taiho products and relevant disease states, and facilitation of clinical research. The Sr . MSL integrates … 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
- 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. (Rahway, NJ)
- …wide range of stakeholders including the Global Project Manager, Alliance Manager, Global Trial Manager, Clinical Sub Team, Clinical Trial Team, ... and improve lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director, the Finance Senior Specialist… more
- Novo Nordisk Inc. (Los Angeles, CA)
- … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... clinical trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team,… more
- Merck & Co. (North Wales, PA)
- …:Serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.Develops individual protocols and ... Involved in research activities for innovative statistical methods and applications in clinical trial development. Minimum education required: PhD or equivalent… 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)
- …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
- 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
- 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. (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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …deliverables across NACD. This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that will ... US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance...Trial sites. Accountable for overall performance management of Senior Supply team, who contribute to the planning, execution… more
- Mindlance (Atlanta, GA)
- …mathematics or related field * Extensive experience of statistics in a clinical trial environment. Evidence of providing expert statistical input in ... Job Title: Sr Biostatistician Job Location: Remote Top 3/5 Skills:...and regulatory knowledge to the department. Acts as the senior reviewer on simple or moderately complex projects, and… 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
- 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)
- …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)
- …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
- 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
