- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... plan by function and team; Interprets and react accordingly to new preclinical/ clinical data(eg; Go/No Go decisions, reprioritization, etc.); Operational Project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... plan by function and team; Interprets and react accordingly to new preclinical/ clinical data(eg; Go/No Go decisions, reprioritization, etc.); Operational Project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …people required7 or More Years managing initiatives requiredCompetenciesEnd-to-end clinical trial experience directing/overseeing data management services ... to function as DM SME in internal audits and/or regulatory on-site inspectionsKnowledge of clinical trial operations, clinical trial data flow,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Research (CESR) projects. Candidates should have a comprehensive understanding of clinical trial management, with firsthand experience managing collaborative ... action items. Coordinate with stakeholders to ensure timely follow-up and resolution of issues. Clinical Trial Management: Oversee clinical trial … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Data Management and Clinical Development. Responsibilities Designs and leads clinical trial sample testing activities and data capture to support CDx ... regulatory submission or associated drug regulatory submissionsResponsible for implementation of clinical trial assays at Diagnostics Partners, reference labs… more
- 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 of the ... our understanding of disease disparities and the effects on clinical trial populations. This role will report... populations. This role will report into the Associate Director , Diversity & Patient Inclusion. Responsobilties: + Drive the… more
- Vitalief (New Brunswick, NJ)
- Overview Vitalief is a pioneering, "best of breed" Research and Clinical Trial Solutions Consulting Company. We are seeking a problem-solving oriented, ... member of our exceptional Client Services Delivery team. The Director will work closely with senior management and our...while balancing costs and quality. + Responsible for enhancing clinical trial execution and enrollment through building… 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
- Pfizer (New York, NY)
- …cultivates collegial relationships with key clinical experts, academic entities, and clinical trial sites, and uses these relationships to help establish ... as a Medically Qualified Individual (MQI) at Pfizer, reviewing clinical trial data for safety signal identification...signal identification and tracking. + Provides input to the operational strategy and feasibility of clinical research… more
- Sanofi Group (Bridgewater, NJ)
- ** Clinical Research Director ** **About the Job**...Reporting to the Global Project Head, the CRD leads clinical trial strategy and execution of assigned ... + Reviews the study specific committee charters. Leads study specific committees with operational support. + Leads the clinical interpretation of study results,… 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 ... together. **Job Description** We are seeking a strong, experienced Clinical Operations leader for a Director position...and indirect reports. You will be accountable for the operational strategy and successful execution of the Clinical… 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …+ Have a strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out) In order to be considered for ... The Senior Medical Director , Clinical Sciences, Hematology provides ...life may include the following responsibilities: + Manages all operational aspects and drives execution of the section of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... plan by function and team; Interprets and react accordingly to new preclinical/ clinical data(eg; Go/No Go decisions, reprioritization, etc.); Operational Project… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …7 or More Years managing initiatives required **Competencies** + End-to-end clinical trial experience directing/overseeing data management services and ... as DM SME in internal audits and/or regulatory on-site inspections + Knowledge of clinical trial operations, clinical trial data flow, pharmacovigilance,… 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
- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Research (CESR) projects. Candidates should have a comprehensive understanding of clinical trial management, with firsthand experience managing collaborative ... around rare diseases and immune disorders. **Summary:** The Associate Director will lead the execution and lifecycle management of...to ensure timely follow-up and resolution of issues. + Clinical Trial Management: Oversee clinical … more
- BMS Family Health and Wellness Centers (Brooklyn, NY)
- …the clients and achieving high levels of patient satisfaction. In collaboration with the Clinical Site Director and other operational staff, ensures optimal ... Of Nursing Brooklyn, NY (http://maps.google.com/maps?q=592+Rockaway+Avenue+Brooklyn+NY+USA+11212) Description The Assistant Director of Nursing has administrative and clinical … more
