- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will ... Action/Preventive Action (CAPA) plans and related effectiveness measures, as appropriate.Responsibilities: Clinical Trial Operational Risk Management:Own, lead and… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for ... pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership ... policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for...experience in procedural writing and life cycle management requiredAdditional clinical trial process experience in one or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he/she will develop a… 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)
- …Data Management and medical coding expertise to promote best practices across the Clinical Trial lifecycle.Applies GCP principles to ensure all medical coding ... end-to-end delivery of medical coding data for assigned projects/studies collaborating with clinical and medical teams, CROs and other vendors to ensure high quality… 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
- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …role is primarily a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy. ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in...to the CRO, but includes ancillary vendors (eg translations, trial insurance, and central laboratory).Work closely and oversee CRO… 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
- Merck & Co. (Rahway, NJ)
- …and sustained. The Sr CCQM Lead supports large to medium size country/cluster clinical trial operations to achieve those objectives. -Under the guidance of ... the Regional Director , Clinical Quality Management (RCQM), and in...functional and/or line management position.Deep knowledge and understanding of Clinical Trial processes, GCP and applicable … 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)
- …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
- Jazz Pharmaceuticals (Palo Alto, CA)
- …studies in the project(s). This position can have direct reports up to Associate Director level, participates in regulatory interactions for the project(s), ... to internal and external audiences.Develop statistical programs as necessary to simulate clinical trial design operating characteristics, simulate clinical … 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
- Bristol Myers Squibb (Princeton, NJ)
- …and implementation of innovative strategies and technologies for clinical trial programming. Associate Director develop collaborative relationships and ... development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Associate Director drives the development… more
- Bristol Myers Squibb (Princeton, NJ)
- …and implementation of innovative strategies and technologies for clinical trial programming. Associate Director develop collaborative relationships and ... development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Associate Director drives the development… more
- Novo Nordisk (Lexington, MA)
- …to make a difference? The Position We are seeking a highly organized and detail oriented Clinical Trial Associate (CTA) to assist with the execution of ... clinical trials. Relationships This position reports to the Associate Director or Director , ...study tracking and reporting and submit them to the Trial Master File within established guidelines, maintain up-to-date documentation… more
