- 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. (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)
- … 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
- 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)
- …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)
- …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
- 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
- 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
- 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 (Rahway, NJ)
- …This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, ... standards internally and externally. Under the oversight of the CRD( Clinical Research Director ) / Director ,...the individual is responsible to manage/oversee a team of CTCs( Clinical Trial Coordinator). As line manager the… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director...clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments + Authors… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director , Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology clinical studies and ... programs. May be responsible to manage one or more clinical scientists. As an Associate Director...clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments. Authors and/or… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …amendments, IRB/IEC submissions and regulatory submissions * Accountable for timely clinical trial execution, reviewing adverse events, monitoring patient ... therapeutic area preferred, along with relevant industry experience. A minium of 2-3yr ( Associate Director ), 4-8yr ( Director ) prior industry experience or… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …direct impact. Join Gilead and help create possible, together. **Job Description** The Associate Director , Clinical Records & Information Management will ... the TMF technical capabilities and oversight of standardization, training, quality, and timely clinical trial documentation across the clinical program. The… more
- Merck (Rahway, NJ)
- …members including clinical directors and study managers to lead/support clinical trial scientific activities. **Job Responsibilities** + Responsible for the ... clinical protocol(s). + Serves as the lead clinical scientist on the clinical trial...clinical data/medical protocol deviations in collaboration with the Clinical Director . + Builds talent and capabilities… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director , Program and Project Planning will be integral in driving a planning culture within the Global Development organization and ensuring data ... in capturing, analyzing, managing and reporting project and portfolio level activities. This Associate Director will serve as a subject matter expert in planning… more
- IQVIA (Queens County, NY)
- …SOPs, policies and practices. **_Immediate need for candidates with CNS Clinical Trial Management experience._** **RESPONSIBILITIES** + Accountable for ensuring ... **PURPOSE** Clinical Leadership is focused on the delivery and...focused on the delivery and quality of the contracted Clinical services within a project to achieve customer satisfaction.… more
