- AbbVie (New York, NY)
- …a framework required by the FDA for all clinical studies (PhIII) to improve clinical trial diversity . With this role, you will be an important member ... populations. This role will report into the Associate Director , Diversity & Patient Inclusion. Responsobilties: +...the strategic implementation of the action plan for AbbVie's Clinical Trial Diversity approach across… more
- Bristol Myers Squibb (Summit, NJ)
- …teams to support clinical development and ensure the integrity and quality of clinical data and clinical trial subject safety. This leader will sit ... the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and proceses/systems, including for-cause and… more
- Bristol Myers Squibb (Berkeley Heights, NJ)
- …of smart systems and optimal approaches to support the end to end clinical trial data lifecycle, from collection through submission. + Holding accountability ... their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , Clinical Data Standards is a leadership...**Experience Requirements** + At least 12 years of global clinical trial expertise and a successful track… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** The Clinical Trial Capabilities (CTC) organization offers infrastructure, support, and ... Operations and Development Organizations with rapid, efficient, and compliant clinical trial execution to deliver transformative medicines to patients.… more
- Merck (Rahway, NJ)
- …Global Development Quality, our Research & Development Division Quality, GCS, Global Clinical Trial Operations (GCTO), Preclinical Development Sciences and ... products? Within our Research & Development Division, the Global Clinical Supply (GCS) organization is accountable for the end-to-end...IT) to serve our company's patients. The GCS Senior Director of Compliance is a key accountable leader on… more
- AbbVie (Florham Park, NJ)
- …Completion of a subspecialty fellowship is desirable. + At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent. + ... to support a global scientific and business strategy. + Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …budgets and timelines. Strong financial acumen necessary for the management of clinical trial budgets. + Demonstrated excellence in complex project management ... help create possible, together. **Job Description** We are seeking a strong, experienced Clinical Operations leader for a Director position within our Oncology… more
- Bristol Myers Squibb (Summit, NJ)
- …Articulating clinical development strategy + Analyzing, interpreting, and acting on clinical trial data to support development + Serving as principal ... talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency,… more
- Mount Sinai Health System (New York, NY)
- …research study team and monitors all safety aspects of clinical research trial (s). Under guidance of the Associate Director of Research and Quality Outcomes, ... Experience: + 3 years of experience in Phase I-IV clinical studies as a clinical trial...adjudication by the CEC. + Participates with the Associate Director of Research and Quality Outcomes in the preparation,… more
- AbbVie (Florham Park, NJ)
- …submitted to the regulatory authorities. + Participation in design and execution of clinical trial safety, product safety and risk management plans. May also ... Adverse Events (SAE's) if assigned to AbbVie conduct on clinical studies. Qualifications Medical Director Qualifications +...fellowship is preferred. + Minimum of 2 years of clinical trial or medical affairs experience in… more
- Mount Sinai Health System (New York, NY)
- …oversight of major regulatory programs as defined and agreed upon with the Senior Director of the Clinical Trial Operations and the Principal Investigator ... all procedures that currently impact the regulation of the clinical trial research portfolio of the Department...of site visits/inspections as necessary. **About Us** **Strength Through Diversity ** The Mount Sinai Health System believes that … more
- Bristol Myers Squibb (Madison, NJ)
- …This includes a centralized triage function for informed consent negotiations with global clinical trial sites, IRBs/ECs, and health authorities, as well as ... Simplification. + Knowledge of IT systems used to support clinical trial processes and the authoring of...talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared… more
- AbbVie (Florham Park, NJ)
- …Completion of residency and/or fellowship is preferred. + Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or ... or equivalent. 3+ years of experience is preferred. + Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements… more
- Bristol Myers Squibb (Madison, NJ)
- …and/or review aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings. . Lead team in the ... [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (eg, protocols, clinical study reports… more
- AbbVie (Florham Park, NJ)
- …for bringing people, process, and technology together to generate business value from clinical trial . Our operational model is exemplified through execution and ... innovation. The Director of Clinical Data Strategy & Operations...to clinical data management. + Understanding of clinical trial methodologies, data collection processes, and… more
- Mount Sinai Health System (New York, NY)
- …* Supportive and experienced clinical staff * State of the art clinical trial unit, clinical and translational research environment and affiliated ... Icahn School of Medicine at Mount Sinai seeks a Director for its Skin of Color Center in Manhattan!**...with a strong academic record of accomplishments and/or academic, clinical and research productivity, impressive publications and a deep… more
- Bristol Myers Squibb (Madison, NJ)
- …and analysis, metrics, and associated targets, and reporting mechanisms including both product/ clinical trial quality and process effectiveness aspects. + Lead ... + Expert understanding of the drug development process and clinical trial execution. + Expert knowledge of...talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared… more
- Sanofi Group (New York, NY)
- …Leaders (KOLs) for peer-to-peer engagement within targeted accounts. + Identify suitable clinical trial and registry sites and provide comprehensive support ... **Job title:** US Rare Disease, Medical Strategic Account Director , East (NJ, NYC) **Location:** Remote/Field **Travel:** Ability...throughout the trial process. + Assist in designing and developing health… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & ... current regulatory requirements and expectation for small molecule arketing applications, clinical trial applications for projects, and/or lifecycle changes to… more
- AbbVie (Florham Park, NJ)
- …on Medical Information (MI) materials. + Participates in design and execution of clinical trial safety, product safety and risk management plans. Track RMP ... in Parkinson's and/or Movement Disorders is preferred. + Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements… more