- Eisai, Inc (Nutley, NJ)
- …GV&A projects related to both clinical trial setting and observational studies .Serve as the lead statistician on project teams, offer statistical insights ... crucial role within the Global Value & Access (GV&A) team , responsible for leading and overseeing statistical activities across... clinical trial data, patient registries, and observational studies ) to support study design and otcomes… more
- Merck & Co. (Rahway, NJ)
- …of Contact (POC) for assigned protocols and link between Country Operations-and clinical trial team (CTT).Responsible for project management of the assigned ... Job DescriptionPosition Description: Clinical Research Manager (CRM) - General Medicine (REMOTE)...Research Manager (CRM) could be responsible for a particular study for several countries in a cluster.Responsibilities include, but… more
- Merck & Co. (Rahway, NJ)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint ... and supervise the activities of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional group of experts in… more
- Eisai, Inc (Nutley, NJ)
- …illness, etc.) as well as the potential for observational health economic studies (prospective or retrospective study of cost and/or outcomes).Conduct systematic ... integral member of the Global Value & Access (GV&A) team and is responsible for the design and implementation...disease processes to understand and evaluate the implications of clinical trials and real-world data; demonstrate the value of… more
- Merck & Co. (Rahway, NJ)
- …simultaneously. Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before ... Job DescriptionOur Regulatory Affairs team bring new medical advancements to the world...submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact… more
- Merck & Co. (Rahway, NJ)
- …authoring for regulatory documents such as Investigational New Drug application, Clinical Study Report, Common Technical Document, and agency- interactions.-You ... and Pharmacometrics --Immune/Oncology-(QP2-IO)- team in the role of-Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization… more
- Pfizer (New York, NY)
- …way in healthcare and make a lasting impact on society.** **What You Will Achieve** As a Clinical Study Team Lead (CSTL), you will be an integral member ... team delivery of multiple complex global studies and/or programs. Your clinical development expertise...operations + Accountable for issue escalation and resolution + Lead study team chartering and… more
- Vitalief (Newark, NJ)
- …bit and occasional weekend work could be required. Responsibilities: + Reporting to a Clinical Trial Recruitment Team Lead , the Recruitment Specialist will ... Clinical Trial Recruitment Specialists to join our exceptional team (as a full-time, fully benefited Vitalief employee) to...work with the Team Lead to research, query and extract data from different… more
- Merck (Rahway, NJ)
- …execution of a clinical trial. * May serve as the clinical trial team lead * May lead team in key study planning, development, and execution ... (eg, study team , country teams, vendors, committees) in support of clinical study objectives. * Accountable for managing any study specific partners… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …as a Clinical Study Lead looks like:** + Leads the cross-functional study team responsible for clinical study delivery and is the primary ... As a Clinical Study Lead (CSL),... Study Lead (CSL), you will lead the cross-functional study team ...studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The **Senior Clinical Study Lead ** (CSL) is...in this role looks like:** + Leads the cross-functional study team responsible for clinical ... studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug...awareness of relevant industry trends + Ability to build, lead and develop productive study teams and… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …Ridge, NJ._ A Clinical Study Associate Manager (CSAM) role supports the Clinical Study Lead (CSL) by taking responsibility for areas of clinical ... will vary accordingly. The individual will work with the study team internally and externally with vendors...regular status reports to stakeholders as requested by the Clinical Study Lead + Contributes… more
- Pfizer (New York, NY)
- …for mitigation + Leader of the Local Study Team (core members: ( Lead ) Site Care Partners Clinical Trial Assistant, ad hoc members: ICL, Site Activation ... The Study Operations Manager has responsibility for study management aspects of assigned studies of...larger Study Management team . The Study Operations Manager I may lead specific… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …assessments that meet customer requirements and appropriate standards. + Plan, conduct, and lead complex clinical study audits (Sponsor, Investigator Sites ... have an excellent new opportunity for a Medical Device Lead Auditor to join our global organization. The successful...candidate will be responsible for planning, conducting and leading clinical audits for in vitro diagnostic medical devices and… more
- Bristol Myers Squibb (Summit, NJ)
- …plans in support of asset strategy with the Early Clinical Development Leadership team ; clinical studies include first-in-human Phase I, proof of concept ... development plan, design clinical trials and lead the clinical development team .... Scientists to allow for protocol-specific training, supporting the study team , investigators, and others + Ad-Hoc… more
- Merck (Rahway, NJ)
- …Procedures (SOPs). Manages several complex activities and study types. Our Clinical Research and Pharmacovigilance team push the boundaries of global ... Description:** **Senior Study Manager - Epidemiology Operations** Support the Lead Epi Scientists by providing overall operational support for study … more
- Pfizer (New York, NY)
- …etc.), and lead translation of pre- clinical observations into clinical experiments and studies designed to demonstrate proof of pharmacology, proof ... **ROLE SUMMARY** The Clinical Lead (CL), Internal Medicine RU...of clinical research plans into efficiently delivered studies . Creative in the conception of novel study… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …reporting of clinical studies for I&I programs. TheDirector, Clinical Science (I&I)will also lead /participate in developing the long-range strategic ... hope for all facing illness. The Director, Clinical Science (I&I) will lead the early- to late-stage development team (s) in designing, planning, implementing… more
- Kedrion Biopharma, Inc. (Fort Lee, NJ)
- … production of primary manuscript publications from completed clinical trials + Lead development and strategy team focused on cutting edge scientific and ... Research teams to drive scientific content of protocols, clinical study reports, clinical investigator...+ In conjunction with Contract Research Organization (CRO) personnel, lead medical oversight of clinical research programs,… more
- IQVIA (Queens County, NY)
- …high quality data collection. The Clinical Lead provides leadership of the clinical team , in support of the project leader, and in collaboration with the ... for Proposals (RFPs). + Participate in bid defense preparations. Lead the Clinical delivery strategy at bid...with the project leaders to confirm objectives of the clinical team according to agreed-upon contract, strategy… more
