Sr Clinical Study Assoc CO Daiichi Sankyo, Inc.Sr Clinical Study Assoc COBasking Ridge, NJ$100,960–$151,440 / yearFull timeKey focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP). With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Clinical Study Manager, Clinical Operations Daiichi Sankyo, Inc.Clinical Study Manager, Clinical OperationsBasking Ridge, NJ$136,080–$204,120 / yearFull timeCRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level. Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables.
Clinical Study Manager, Global Clinical Operations Daiichi Sankyo, Inc.Clinical Study Manager, Global Clinical OperationsBasking Ridge, NJ$136,080–$204,120 / yearFull timeCRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level. Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables.
NewAssociate Director, Clinical Science Daiichi Sankyo, Inc.Associate Director, Clinical ScienceBasking Ridge, NJ$162,400–$243,600 / yearFull timeUnder supervision of Clinical Science Asset Lead or Clinical Science Lead, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Provides strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan and to Clinical Operations on SDV plan.
Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
Executive Director, Global Clinical Lead Daiichi Sankyo, Inc.Executive Director, Global Clinical LeadBasking Ridge, NJ$329,025–$548,375 / yearFull timeProvides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO/ARO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept. Study planning and execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level.
Senior Director, Clinical Development - Hematology Daiichi Sankyo, Inc.Senior Director, Clinical Development - HematologyBasking Ridge, NJ$280,350–$467,250 / yearFull timeMay contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Senior Director, Clinical Development Daiichi Sankyo, Inc.Senior Director, Clinical DevelopmentBasking Ridge, NJ$280,350–$467,250 / yearFull timeMay contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Director, Clinical Safety ScientistBasking Ridge, NJ$201,840–$302,760 / yearFull timeRisk Management (Signal identification, evaluation, mitigation): Is a key participant in developing and implementing the risk management strategy for assigned products/ TAs; Independently integrates and analyzes safety data from multiple sources to deliver comprehensive conclusions; Independently identifies gaps in safety surveillance plans/RMPs and escalates appropriately. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Executive Director, Head of Clinical Supply Planning and Operations SCM Daiichi Sankyo, Inc.Executive Director, Head of Clinical Supply Planning and Operations SCMBasking Ridge, NJ$255,000–$425,000 / yearFull timeAdditionally, as the regional head of DSI (US) CSO, this position will 1) Oversee all the Clinical Supply Operation-related functions in DSI, 2) Ensure alignment between DSI-CSO and TECH Unit sub-functions (Project Lead (CMC), Regulatory Affairs CMC, Process Technology Research, Formulation Technology Research, and Analytical & Quality Evaluation Research), 3) Make the best effort to increase the total performance of the TECH Unit. Responsible for leading all Clinical Supply Operation (CSO)-related activities for oncology and specialty medicine drug candidates from early development to launch and life cycle management of products globally to achieve the business success of Daiichi Sankyo Group and managing the Global-CSO function from Daiichi Sankyo Inc. (DSI).
Clinical Nutrition Director - RWJBH Children's Specialized AramarkClinical Nutrition Director - RWJBH Children's SpecializedNew Brunswick, NJ$125,000–$145,000The director is responsible for overseeing all aspects of nutritional care, ensuring that services meet the complex medical, developmental and psychosocial needs of children with unique and chronic health care needs. Bachelor?s degree in dietetics, foods and nutrition, or related area, granted by a U.S. regionally accredited college or university, or foreign equivalent.
Regional Sales Manager - Clinical EHR Systems - NJ Michael Page USARegional Sales Manager - Clinical EHR Systems - NJWork from Home, NJ$100,000–$150,000 / yearFull timeHaving achieved success with a lean commercial organization, leadership is now investing in strategic sales growth to capitalize on significant market opportunities across independent practices, specialty groups, IPAs, MSOs, and other ambulatory care providers. Their platform combines Electronic Health Records (EHR), practice management, and revenue cycle capabilities to help providers improve operational efficiency, enhance patient care, and navigate the evolving demands of modern healthcare.
Manager, Global Vendor Quality, Global R&D & PV QA Daiichi Sankyo, Inc.Manager, Global Vendor Quality, Global R&D & PV QABasking Ridge, NJ$127,280–$190,920 / yearFull timeThis position focuses on operational execution, oversight, and continuous improvement of vendor quality activities, contributing subject-matter expertise while working under the direction of senior vendor quality leadership. The Manager, Global Vendor Quality (Global R&D & PV QA) supports the development, implementation, and execution of the GCP/GLP/GVP vendor quality program across Daiichi Sankyo group companies.
Director, Risk Based Quality Management (RBQM) Daiichi Sankyo, Inc.Director, Risk Based Quality Management (RBQM)Basking Ridge, NJ$201,840–$302,760 / yearFull timeOversee RBQM activities for Daiichi Sankyo Portfolio of Studies: Serve as senior level technical RBQM SME and oversee Central Risk Managers to ensure proper implementation and execution of RBQM and inspection readiness. Interacts with and influences internal and external executive level and study level stakeholders on risk based quality management principles, process improvement, metrics design and application and other key drivers of enhanced quality.
Senior Clinical Data Manager Everest Clinical ResearchSenior Clinical Data ManagerBridgewater, New JerseyRemoteTo drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Data Managers for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy. Is responsible for planning and implementing data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting.
Clinical Research Coordinator Sr. Hassman Research Institute, LLCClinical Research Coordinator Sr.Marlton, NJ$35–$41 / hourPart timeIndependently responsible for coordinating all aspects of multiple and/or complex clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members.
Clinical Research Coordinator II Hassman Research Institute, LLCClinical Research Coordinator IIMarlton, NJ$26.24–$33.51 / hourPart timeRecently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.
Senior Clinical Director, Clinical Research, Hematology Merck & Co IncSenior Clinical Director, Clinical Research, HematologyNJ$282,200–$444,200 / yearThe Senior Clinical Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Oncology therapeutic area, specifically in our Hematology Section. The Senior Director is responsible for maintaining a strong scientific fund of knowledge by: Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies.
Clinical Director, Clinical Research, Hematology Merck & Co IncClinical Director, Clinical Research, HematologyNJ$255,800–$402,700 / yearThe Clinical Director is responsible for maintaining a strong scientific fund of knowledge by: Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies. The Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Oncology therapeutic area, specifically in our Hematology Section.
Clinical Research Coordinator Sr. CenExelClinical Research Coordinator Sr.Marlton, New JerseyIndependently responsible for coordinating all aspects of multiple and/or complex clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members.
Clinical Research Coordinator III Rutgers The State University of New JerseyClinical Research Coordinator IIIPiscataway, NJUnder Policy 100.3.1 Immunization Policy for Covered Individuals, if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption. With its broad and multidisciplinary faculty expertise, the Environmental and Occupational Health Sciences Institute (EOHSI) is an international resource that supports basic and clinical research in environmental health sciences and exposure assessment and fosters associated programs in environmental health education and public policy.
NewClinical Research Associate Integrated Resources, IncClinical Research AssociateSouth Plainfield, New JerseyFull timeJOB RESPONSIBILITIES:Support project management oversight of Clinical Development activities for multiple domestic and international trials, including:Track study timelines;Review and track study budgets;Provide periodic updates on Clinical DevelopmentGradually develop responsibilities for management of contract research organization (CROs) activities for clinical and data managementProvide monitoring support, in some cases functioning as the primary site monitor. Job DescriptionThe Clinical Research Associate for Clinical Operation will provide site monitoring and management oversight across multiple clinical research trials in support of development of Pharmaceutical's drug pipeline.
Clinical Research Coordinator II CenExelClinical Research Coordinator IIMarlton, New JerseyRecently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.
Senior Manager, Clinical Programming in Princeton, New Jersey, United States of America | Development Operations at Genmab Government of DenmarkSenior Manager, Clinical Programming in Princeton, New Jersey, United States of America | Development Operations at GenmabPrinceton, NJSenior Manager, Clinical Programming in Princeton, New Jersey, United States of America | Development Operations at Genmab Skip to main content Skip to main content Healthcare Professionals Patients & Care Partners Partnerships Contact Working at Genmab Career Areas Application Process Locations Talent Community Job Search Corporate Sign in Close the popup Sign in to Phenom Careers Enjoy a personalized jobs search Sign in with Google Employee Login Sign in with Google Sign up Saved jobs (0) Healthcare Professionals Patients & Care Partners Partnerships Contact Saved jobs (0) Toggle navigation - - Recruitment Fraud Warning: Please note that Genmab never requests payment, banking details, or Social Security numbers during the recruitment process. Close Covid-19 banner Senior Manager, Clinical Programming Category Development Operations Job Id R14378 Remote This job available in 3 locations Princeton, New Jersey, United States of America Copenhagen, Capital, Denmark Utrecht, Netherlands Save Apply Now We are extra[not]ordinary*(ex· tra· not· or· di· nary |\ ik- str-not- r-d - ner- ) Adjective: A unique word for Genmab meaning to go way beyond what is usual; to be remarkable; proudly unique and authentic Back to search results Previous job Next job JOB DESCRIPTION At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases.
NewClinical Project Manager Integrated Resources, IncClinical Project ManagerSouth Plainfield, New JerseyContractorThe Clinical Program manager is the first-line administrator within the Clinical Operations group responsible for the planning, implementation, coordination, supervision and execution of assigned Clinical Trial(s) activities throughout the entire lifecycle. Clinical Project ManagerIntegrated Resources, Inc., is led by a seasoned team with combined decades in the industry.
Clinical Study Manager, Global Clinical Operations - 30014765 Daiichi Sankyo Co LtdClinical Study Manager, Global Clinical Operations - 30014765Basking Ridge, NJ$133,600–$200,400 / yearCRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work within timelines and budget at a task level. Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables.
Clinical Research Coordinator I Hassman Research Institute, LLCClinical Research Coordinator IMarlton, NJPart timeResponsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.
Clinical Research Associate (CRA) - Oncology (Remote) Merck & Co IncClinical Research Associate (CRA) - Oncology (Remote)NJRemote$96,200–$151,400 / yearConducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
Clinical Research Associate (CRA) - Cardiovascular (Remote) Merck & Co IncClinical Research Associate (CRA) - Cardiovascular (Remote)Rahway, NJRemote$96,200–$151,400 / yearConducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
Clinical Database Designer I Everest Clinical ResearchClinical Database Designer INew JerseyRemoteEverest Clinical Research (“Everest”) is a full-service, global, contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading, participating in relevant training, and/or associated activities.
NewLead Clinical Research Associate Integrated Resources, IncLead Clinical Research AssociateRaritan, New JerseyFull timeThe LCRA acts as a primary liaison between Field Based CRAs and the Clinical Project Lead (CPL).Additional responsibilities include:• Implementation of enrollment and recruitment strategies• Assistance in vendors' selection processes• Development, execution, management and compliance assurance of the Monitoring Plan• Review and approve trip reports, track scheduling, report submission metrics, site deviations and action items• Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.• Job DescriptionTitle: Lead Clinical Research AssociateLocation: Raritan, NJ 08869Responsibilities:Lead Clinical Research Associate:Under supervision of Clinical Project Lead, oversees performance of assigned field monitors and site activities in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations.
NewSr. Clinical Project Manager Integrated Resources, IncSr. Clinical Project ManagerSouth Plainfield, New JerseyContractorIt is a Contract-to-Hire position (the contract will last 90 days, after which the position will turn permanent provided the contract period is successfully completed).Will manage several (4-5) projects simultaneouslyMust have Pharma / BioPharma experience (any blood-based experience a plus)Able to interface with Clinicians, MD's, Finance and managementTrack/manage resources and project tasks and report status to managementMust have good communication skills to interface withMinimal US-based travel (10-15%).Job Clinical Project ManagerA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
Sr. Director, Clinical Research Colgate-Palmolive CoSr. Director, Clinical ResearchPiscataway, NJ$250,000–$275,000 / yearEstablished in 1806 as a small soap and candle business in New York City, Colgate-Palmolive is now a truly global company with products sold in over 200 countries and territories under such internationally recognized brand names as Colgate, Palmolive, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, elmex, Tom's of Maine, Sanex, Ajax, Axion, Soupline, Haci Sakir, Suavitel, PCA SKIN, EltaMD, Filorga and Hello as well as Hill's Science Diet and Hill's Prescription Diet. Develop new clinical indices and biochemical assessments and apply a broad range of established dental assessment indices (e.g., caries, plaque, gingivitis, periodontology, sensitivity, whitening, calculus, oral malodor, anti-bacterial or others) to design, evaluate, and differentiate clinical programs and product performance that are superior to, existing products.
Senior Clinical Database Designer I Everest Clinical ResearchSenior Clinical Database Designer INew JerseyRemoteDevelop new features and functionality within the database design functional areas to increase the efficiency of database design at the study level, and to improve and enhance the company’s database design capabilities. Everest Clinical Research (“Everest”) is a full-service, global, contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.
Clinical Research Coordinator I CenExelClinical Research Coordinator IMarlton, New JerseyResponsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.
Clinical Research Change Management Consultant VitaliefClinical Research Change Management ConsultantNew Brunswick, NJRemotePart timeThe ideal candidate brings deep expertise in organizational transformation and change management within complex healthcare and research environments, with a proven ability to drive stakeholder alignment, operational adoption, and sustainable process improvement across multi-site systems. Conduct in-depth interviews with clinical research staff and stakeholders across the clinical trial lifecycle to identify operational gaps, bottlenecks, communication challenges, and improvement opportunities across Oncology and Non-Oncology programs.
Sr. Director, Clinical Research (Piscataway, NJ, US) Colgate-Palmolive CompanySr. Director, Clinical Research (Piscataway, NJ, US)Piscataway, NJ$250,000–$275,000 / yearDevelop new clinical indices and biochemical assessments and apply a broad range of established dental assessment indices (e.g., caries, plaque, gingivitis, periodontology, sensitivity, whitening, calculus, oral malodor, anti-bacterial or others) to design, evaluate, and differentiate clinical programs and product performance that are superior to, existing products. The ideal candidate is an internationally renowned expert in oral health and dental clinical research, with substantial industry and/or academic experience, a proven track record of leading clinical programs, and demonstrated strength in people leadership and collaborative partnerships.
NewClinical Project Scientist Integrated Resources, IncClinical Project ScientistRaritan, New JerseyContractorIn concert with the Associate Director, Clinical Project Scientist, the contractor CPS will direct the overall coordination and management of CVM MA clinical studies including: working in a highly matrix organization, the contract CPS will play a key role in interfacing with our partners to contribute to concept and protocol development, drive accurate budget forecasting and communicate variances, provide project management across the study to drive metrics and alignment to timelines, facilitate critical path analyses and optimization/contingency planning, escalate issues as appropriate for timely resolution, provide updates to senior management as directed.2. Job DescriptionRESPONSIBILITIES:Clinical Project Scientist - Cardiovascular Metabolism (CVM) Medical AffairsThe Clinical Project Scientist (CPS) is a key interface role in the CVM Medical Affairs (CVM MA) organization responsible for collaborating with therapeutic area teams to act as a liaison between therapeutic strategy and the clinical and operational implementation of product programs and clinical studies.
Senior Program Manager - Medical & Clinical Affairs ConvaTec Group PlcSenior Program Manager - Medical & Clinical AffairsBridgewater, NJRemotePosition Overview: As part of the Project and Portfolio Management team for Medical and Clinical Affairs, the Sr Program Manager oversees the project management, planning, execution, tracking, and reporting of clinical studies and/or research projects in accordance with agreed upon resourcing, timing, and budget. Leader and team-worker who actively looks to develop themself and others; proactively networks across a complex organizational hierarchy and works cooperatively and effectively with others to set goals and resolve problems.
Executive Director, Product Development Team Leader, Clinical Research, Hematology - Lymphoma Merck & Co IncExecutive Director, Product Development Team Leader, Clinical Research, Hematology - LymphomaNJ$310,900–$489,400 / yearWorking closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects, and assist the Associate Vice President and/or Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs, and of internal and external expert opinion on scientific questions relevant to their areas of responsibility. Leading internal governance presentations to senior management and committees, communicating progress and key changes in product development strategy between stage gates, ensuring early alignment with line management, and facilitating issue escalation and cross-functional collaboration as needed for governance approval.
Senior Manager, Clinical Scientist Gan & Lee PharmaceuticalsSenior Manager, Clinical ScientistNJFull timeExperiences in metabolic diseases (Diabetes, Obesity, NASH, NAFLD, etc.), Endocrinology (CKD, CRF, etc.), and Nutrition and Weight Management related drug development are a plus. The position will work with Gan & Lee clinical program lead(s) to provide the scientific and clinical leadership and inputs in meeting the development objectives for the program.
Senior Scientist, Clinical Research Merck & Co IncSenior Scientist, Clinical ResearchRahway, NJ$117,000–$184,200 / yearCo-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts. Experience managing Immunology and/or vaccine trials with an ability to think outside of the box, explore novel ways of working and comfortably navigate ambiguity to drive results also a plus.
Clinical Research Nurse Hackensack Meridian HealthClinical Research NurseNeptune, New JerseyFull timeAssists the principal investigator in the preparation of proposed clinical trials by reviewing trial protocol, contacting each department who will provide resources during study and ensuring appropriate departments are notified and given a copy of proposed trial, scientific merit and accrual potential. Performs nursing assessments and monitors study patient`s progress during clinical trials; Tracks study patient`s response by documenting on toxicity flow sheet, medication flow sheet and nurses` progress notes.
Distinguished Scientist, Product Development Team Leader, Clinical Research - GI oncology Merck & Co IncDistinguished Scientist, Product Development Team Leader, Clinical Research - GI oncologyRahway, NJ$310,900–$489,400 / yearWork closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs, statistics, medical affairs and manufacturing to manage clinical development projects; and assist the Associate Vice President in ensuring that appropriate Corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility. Required Skills: Clinical Development, Clinical Trials, Clinical Trials Monitoring, Cross-Functional Teamwork, Drug Development, Gastrointestinal Cancer, Leading Project Teams, Oncology Trials, Research Methodologies, Results-Oriented, Scientific Leadership, Strategic Leadership.
Clinical Trial Manager KardiganClinical Trial ManagerPrinceton, New JerseyThis position will be responsible for the oversight and management of Clinical Research Organizations (CROs) and vendors and will work cross-functionally on the trial operations’ strategy and related initiatives. Supports the Clinical Trial Lead (CTL) in the oversight and management of study CROs to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
Oncology Clinical Research Nurse - JS Hope Tower - F/T Days Hackensack Meridian HealthOncology Clinical Research Nurse - JS Hope Tower - F/T DaysNeptune, New JerseyFull timeResponsibilities: Assists the principal investigator in the preparation of proposed clinical trials by reviewing trial protocol, contacting each department who will provide resources during study and ensuring appropriate departments are notified and given a copy of proposed trial, scientific merit and accrual potential. Performs nursing assessments and monitors study patient`s progress during clinical trials; Tracks study patient`s response by documenting on toxicity flow sheet, medication flow sheet and nurses` progress notes.
Senior Manager, Clinical Programming Genmab ASSenior Manager, Clinical ProgrammingPrinceton, NJFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
Clinical Trial Liaison Manager Recordati SpAClinical Trial Liaison ManagerBridgewater, NJHighly desirable but not required: Experience supporting regulatory submissions, previous roles working as a CTLM, study coordinator, research nurse, or in Med Affairs Operations, formal Project Management training or certification, and working with rare diseases. The CTLM represents RRD in site relations, supports study teams with startup and recruitment, and manages in-field activities of the contracted CRO, focusing on the CRA team.
Sr. Manager, Clinical Trial Operations Planning & Analytics Legend Biotech CorpSr. Manager, Clinical Trial Operations Planning & AnalyticsSomerset, NJ$127,313–$167,099 / yearHeadquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. The position partners closely with Clinical Operations leadership and cross-functional stakeholders to determine and assess assumptions, refine strategy, and translate data into actionable operational decisions across the study lifecycle.
Principal Scientist, Clinical Research - Immunology/Dermatology Merck & Co IncPrincipal Scientist, Clinical Research - Immunology/DermatologyRahway, NJ$255,800–$402,700 / yearAssist the Senior Director, Associate Vice-President/Vice-President and Product Development Team Lead in ensuring that appropriate corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.