- 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
- 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
- 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)
- …Times, Identity key milestones at Study, Country, and Site Level to gauge clinical trial performance. Build and Maintain Metrics Catalog, Dashboards Catalog ... of Metrics, KPIs, KRIs and KQIs related to large scale global clinical trial end to end execution. preferredDemonstrated ability to influence at all senior… 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
- 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)
- …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)
- …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
- 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
- University of Utah (Salt Lake City, UT)
- …City, UT **Track** **New Position to Begin** As soon as possible **Details** ** CLINICAL TRIAL AND TRANSLATIONAL RESEARCH , BREAST MEDICAL ONCOLOGY** **Huntsman ... post-doctoral training; 2) Must have an established track record of clinical trial leadership/enrollment and scientific accomplishments with extramural industry… more
- University of Colorado (Aurora, CO)
- Associate Director or Director of Clinical Research - 33685 University Staff **Description** **University of Colorado Anschutz Medical Campus** ... **Department: Gates Institute** **Job Title: Associate Director or Director of Clinical ...and execution of trial activities. At the Director level, this role will strategically lead clinical… more
- AbbVie (CA)
- …visit https://global.allerganaesthetics.com/. Follow Allergan Aesthetics on LinkedIn. Job Description The Associate Director , Clinical Development will have ... Program Lead and Clinical Science Lead and Clinical Scientist. The Associate Director ,...responsible for: + Ensuring alignment between the IEST, and Clinical Trial Team(s) + Developing the proposed… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Clinical Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #367 Wednesday, May 8, 2024 Looking for a chance to make a meaningful ... and manages multiple complex global studies to support the Clinical Development Plan. The Associate Director...budget, recruitment and country/site selection strategies, and provision of clinical trial materials. + Serves as main… more
