- Merck & Co. (Rahway, NJ)
- …BS degree in relevant discipline.-Knowledge and Skills:--Minimum 6 years' experience in Clinical Data Management or Pharmacovigilance as appropriate to business ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide...teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs,… more
- Insight Global (Basking Ridge, NJ)
- Job Description The DG Analyst ( Clinical Operations) will be key participant in data quality and governance activities related to the clinical study ... focus on the clinical operations and related data (not on patient level data ). As...consensus, and contribute to and/or have responsibility for producing data governance deliverables such as process/ data… more
- Mount Sinai Health System (New York, NY)
- …exchange, while ensuring compliance with data privacy regulations like HIPAA. ** Data Governance , Policy Development, Performance Monitoring and Data ... Data Engineering - Digital and Technology Partners - Remote - Req#3016788** The Director of Enterprise Data...Quality Assurance** + Establish and uphold data governance frameworks and policies, ensuring data integrity,… more
- Bristol Myers Squibb (Madison, NJ)
- …and CRA training materials and present these at SIVs and Investigator meetings + Review clinical narratives + Monitor clinical data for specific trends + ... data collection in alignment with the protocol in collaboration with Data Management/Programming + Submit clinical contributions to clinical study… more
- Bristol Myers Squibb (Summit, NJ)
- …include developing and presenting protocol documents, conducting literature reviews, monitoring clinical data , and contributing to clinical study ... and ICF documents / amendments and present these to governance committee and development team meetings as required +...present these at SIVs and Investigator meetings + Review clinical narratives + Monitor clinical data… more
- Bristol Myers Squibb (Summit, NJ)
- …and pharmacometric support for all pipeline assets throughout the clinical development lifecycle. Composed of pharmacologists, pharmacometricians, data ... + **Represent** Clin Pharm on asset teams and at governance meetings based on proficiency + **Provide input** to... Clinical Pharmacology Plan + **Lead** design of clinical pharmacology studies and manages data analysis,… more
- Organon & Co. (Jersey City, NJ)
- …will work collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, ... GCP, ICH and other regulatory standards. + Ability to understand and interpret clinical and scientific information and data and communication thereof in written… more
- J&J Family of Companies (Raritan, NJ)
- Senior Principal Scientist, Clinical Pharmacology and Pharmacometrics - 2406213334W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Senior ... Principal Scientist, Clinical Pharmacology and Pharmacometrics, located in Spring House, PA...Pharmacometrics, located in Spring House, PA or Raritan, NJ. Remote work options within the US may be considered… more
- RWJBarnabas Health (West Orange, NJ)
- …Category Assigned Status:Full-Time Shift:Day Facility:RWJBarnabas Health Corporate Services Department:Ent. Data & Analytics Location: SBC Corporation, 95 Old Short ... Research reports + Minimum of Associate s Degree or 3+ years prior Data Analytics and report writing experience + Demonstrated ability to support the application… more
- Bristol Myers Squibb (Madison, NJ)
- …Summary** Global Data Management (GDM) is responsible for clinical trial data acquisition, data standards governance , data management, medical ... position. **Position Responsibilities include:** + Providing leadership of external clinical data acquisition and integration activities across multiple… more
- Bristol Myers Squibb (Summit, NJ)
- …responsible for assisting with the implementation and management of Bristol Myers Squibb's GMP Data Governance and Data Integrity program at the Summit West, ... Shift, 8 am - 5 pm **Responsibilities:** + Responsible for executing data integrity documentation periodic reviews and performing risk monitoring of implemented… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …have exceptional background in data engineering (including software engineering principles), data systems, and data governance and will be comfortable ... the way medicine is made by harnessing the power of computer and data science, artificial intelligence, and other technologies to promote robust products and… more
- Bristol Myers Squibb (Madison, NJ)
- …with stakeholders and SMEs, BMS Global IC templates for use in BMS-sponsored clinical trials. + Ensure appropriate governance and oversight is in place ... for managing the end-to-end process for IC for BMS-sponsored clinical trials. This includes a centralized triage function for...to document permissions and restrictions associated with specimens and data . The AD will also assist in the development… more
- Bristol Myers Squibb (Madison, NJ)
- …plan, incl., clinical plans and labeling strategy; Appreciates translation of clinical data into claims and considerations for label development + ... readout + Has an active role in analysis and/or interpretation of clinical data and translation into scientific communication strategy, including publications,… more
- Bristol Myers Squibb (Summit, NJ)
- …and validation partnering with Translational Sciences colleagues when applicable + Manages clinical biomarker data delivery and analysis and associated timelines ... late stage TM group. The individual will be responsible for TM and clinical biomarker activities to support drug development programs in multiple diseases in… more
- Bristol Myers Squibb (Madison, NJ)
- …compounds within a therapeutic area. Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to ... will support regulatory approval and market access. Contributes to Clinical Development Plans, submissions, and post-submission strategies, preparations, and… more
- Merck (Rahway, NJ)
- …in relevant discipline. **Knowledge and Skills:** + Minimum 6 years' experience in Clinical Data Management or Pharmacovigilance as appropriate to business role ... **Job Description** Our Clinical and Pharmacovigilance teams manage studies to provide...teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs,… more
- NYU Rory Meyers College of Nursing (New York, NY)
- …provide legal counsel and support on a variety of corporate, transactional, governance , and compliance matters for the University. The position will be responsible ... affiliations, exchanges, joint programs, and research activities; and supporting governance for both the University and its affiliates including organizing… more
- Merck (Rahway, NJ)
- …long-term supply. + Represents CMC and effectively communicates across the governance bodies, stakeholders, and team to drive outcomes/decisions through influence, ... early development through to commercial manufacturing. Deep understanding of connectivity between clinical , CMC, and HH to successfully launch a new product. +… more
- Bristol Myers Squibb (Madison, NJ)
- …to the project and any changes are highlighted appropriately. + Advises on governance expectations and prepares for key decision point discussions with focus on ... manages preparation of high-quality documents and presentations for review at governance committees. + Ensures appropriate team membership during the progression of… more
