- 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 ... identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial ...data activities required7 or more years experience in Oncology trials with an understanding of the complex and interdependent… 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)
- …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. (Rahway, NJ)
- …and SAP team members to further extend capabilities and functionalities on our existing Clinical Trial Supply Management (CTSM) solution in order to satisfy and ... Management and Distribution areas with a strong focus in Clinical Trial Supply Management (CTSM) is highly...support of- SAP applications across all functional areas supporting Clinical Trials . This includes leading or contributing… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and standards. This position ensures quality delivery of medical coding for clinical trials , clinical development, and regulatory submissions. Develops ... strategies for medical coding and coding dictionary ensuring all clinical trials meets quality requirements and best...medical coding expertise to promote best practices across the Clinical Trial lifecycle.Applies GCP principles to ensure… 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
- Insmed Incorporated (Jacksonville, FL)
- …strong related experience. Other Pharmaceutical experience - Medical Information, Medical Strategy, Clinical management/ trial experience and 2 years clinical ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Capture, synthesize and deliver HCP derived scientific… more
- Merck & Co. (Rahway, NJ)
- …more novel quantitative approaches that seek to improve cycle time, cost/size, number of trials , clinical trial design and Go/No Go decisionsFraming critical ... of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate… 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
- 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...section development, study setup, execution, analysis, and reporting of clinical trials , and interacts with cross-functional teams.ResponsibilitiesAdditional… 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 ... proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming preferred- 7 or More Years proven… 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, ... of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required Demonstrates technical expertise within Clinical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIt is critical that, for all company-sponsored clinical trials , patient safety, high quality data and compliance with company requirements and ... Sr CCQM Lead supports large to medium size country/cluster clinical trial operations to achieve those objectives....achieve those objectives. -Under the guidance of the Regional Director , Clinical Quality Management (RCQM), and in… more
- Merck & Co. (North Wales, PA)
- …and manufacturing to manage clinical development projects; andAssist the Senior Director , Executive Director , and/or Associate Vice President in ensuring ... with talented and dedicated colleagues while developing and expanding your career.The Clinical Director (Principal Scientist) has primary responsibility for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred Experience- 7 or More Years Outsourcing, health sciences or related field ( clinical trials ) required- 7 or More Years Deep experience in pharma ... & category management required- CRO experience preferred- Strong knowledge of clinical trials preferred- Demonstrated ability to leverage digital data… more
- Insmed Incorporated (Bridgewater, NJ)
- …assays (eg M10 Bioanalytical Method Validation).Familiarity and experience in establishing clinical biomarker analyses for clinical trials .Strong ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… 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)
- …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
