- 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
- 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)
- …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
- 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)
- …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
- 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
- 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
- UT Health (Houston, TX)
- Senior Manager Clinical Trial Program - Pediatric Surgery **Location:** Texas Medical Center-Houston, Texas **Category:** Research McGovern Medical School at ... Manages subject recruitment, site development, enrollment of human subjects and clinical trial monitoring. **Position Key Accountabilities:** + Manages all… more
- IQVIA (Durham, NC)
- Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' ... by bringing new drugs to the market faster. The Senior Clinical Lead is a member of...Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying… more
- Intra-Cellular Therapies, Inc (New York, NY)
- …the Clinical Operations Department as a ** Clinical Trial Manager /** ** Senior Clinical Trial Manager** who plays an important role in the ... oversees vendor performance. + Reviews all operational study plans ( project management plan, monitoring plan, communications plan, TMF plan)...or any other legally protected status. Clinical Trial Manager/ Senior Clinical Trial… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Senior Associate Director, Clinical Trial Diversity supports the Clinical Development & Operations (CD&O) strategy for Diversity & ... requirements. + Supports the development and execution of Diversity & Inclusion in clinical trial strategies, core processes and best practices. + Partners with… more
- Actalent (Remote, OR)
- …identification) Education: Minimum Bachelors (Masters Preferred) Direct experience managing global clinical trial operations is a must, including experience ... Description: The Temp- Senior Manager, Global Trial Optimization (GTO)...of continuous improvement activities to ensure consistency of Global Trial Optimization process execution. In partnership with Clinical… more
