- 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
- Merck & Co. (North Wales, PA)
- …including clinical directors and study managers to lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical ... /scientific execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical trial team.Collaborates with the Medical Writer on … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… 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 ... ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and...US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance… more
- Merck & Co. (Rahway, NJ)
- …to join the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams of… 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 ... leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and updates… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... (popPK), PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data management… more
- Merck & Co. (North Wales, PA)
- …via initiatives, mentoring, process improvements, and/or innovationsStrong knowledge of clinical trial methodology, statistical concepts, and evaluation and ... interpretation of complex scientific literatureCritical thinking skills and ability to consolidate and understand complex data setsStrong medical communications (oral and written) and presentation skillsDemonstrated emotional intelligence and interpersonal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …degree preferred A minimum of ten (10) years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, or CRO required, ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...processes (ie automation, technology, process optimization). Relationships Reports to Director or above within CMR Training & Knowledge Management.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will...its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... study findings through presentations and/or publications in peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …comprehensive Data Management expertise to promote best practices across the Clinical Trial lifecycle.Qualifications: Successful candidates will be able to ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
- Merck & Co. (Rahway, NJ)
- …innovation and improve lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director , the Finance Senior ... the Global Project Manager, Alliance Manager, Global Trial Manager, Clinical Sub Team, Clinical Trial Team, Outsourced Trial Team, and Partnerships,… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director of Biostatistics is responsible for the statistical ... aspects for complex clinical trial (s) or indication product line. This role leads the protocol statistical section development, study setup, execution, analysis,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to seek alignment and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge Management. ... is preferred A minimum of eight (8) years of progressively responsible clinical development/ trial experience within a pharmaceutical, biotechnology, or CRO… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking an ** Associate Director - Clinical Trial Management** to join our Oncology team as a part of our new Regeneron Cell Medicines (RCM) group. ... collaborators, and identification of project risks and contingency planning. **As an Associate Director - Clinical Trial Management, a typical day might… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Senior Associate Director , Clinical Trial Diversity supports the Clinical Development & Operations (CD&O) strategy for Diversity ... goals and strategies for diverse patient enrollment. The Senior Associate Director monitors progress intervenes as necessary...the development and execution of Diversity & Inclusion in clinical trial strategies, core processes and best… more
