- 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 ... - Leadership, Direction, and Strategy:Leads implementation of Therapeutic level clinical data collection requirements including cross-functional standards… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have ... trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team Leader for the… more
- Novo Nordisk Inc. (WA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in...validity and completeness of data collected at clinical trial sites in accordance with the protocol, Monitoring… more
- Merck & Co. (Rahway, NJ)
- …site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.Actively develops and expands ... the territory for clinical research, finding and developing new-sites.-Participates in internal meetings...& oversight activities using various tools to ensure: 1) Data generated at site are complete, accurate and unbiased.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other ... development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …applications and best practices as well as strong technical skills in working with ( clinical ) data . The position holder will require strong skills in continuous ... understanding and translation of business needs to AI/ML tasks, over data understanding and preparation, to modeling, validation and dissemination- Identify… 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 ... along TA and/or functional lines. - -This includes line management of Country Clinical Quality Managers (CCQMs) and Associate Country Clinical Quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards, and coding library management.Manages, reviews and approves medical coding of clinical data ensuring high quality; creates and manages the ... immune disorders. Summary Position manages the end-to-end delivery of medical coding data for assigned projects/studies collaborating with clinical and medical… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director. The team is part of the Global Clinical Development ... organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director, Quantitative Systems Pharmacology (QSP) will work within the Quantitative ... Clinical Pharmacology (QCP) group to develop and apply QSP...virtual population workflow is desirableExperience with general programming and data analysis tools/languages such as Python or R would… more
- Merck & Co. (Rahway, NJ)
- …a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position will report to the Director, ... infrastructure.- Responsibilities include the following:The process/facility engineer role at the Associate Director level will serve as a technical mentor and… more
- Aequor (Thousand Oaks, CA)
- …Receipt (POR) Temperature Data Review and Assessment: - Review the temperature data from shipments to clinical sites - Assess temperature excursion events ... more of a preference. We can train candidates on our QMTS roles. Associate Supply Chain Description: Candidates will, under limited supervision and in compliance… more
- Merck & Co. (Rahway, NJ)
- …systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine ... Job DescriptionThe Associate Principal Programmer leads the statistical programming activities...to quality, compliance and timeliness requirements.-Expertise in SAS and clinical trial programming including data steps, procedures,… 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 ... PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs… 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 ... review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...you ready to make a difference? The Position The Associate Director, Medical Affairs Omnichannel Engagement, role is to… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you.The Associate Director, Strategic Content Development, Global Medical Affairs - Alzheimer's Disease, in ... to the AD portfolio and continued support as a key partner to Clinical Development, Real World Evidence and Commercial Operations.The incumbent will provide disease… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence ... management and implementation planning, for GOCD non-project related initiatives. The Associate Director, GOCD Functional Excellence must have excellent verbal and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
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