NewManager, R&D Quality Risk Management III Iconma LLCManager, R&D Quality Risk Management IIIPrinceton, NJWork in close collaboration with colleagues in R&D Quality Management, client operational units in Drug Development (Clinical Development, Clinical Operations, Data Management, Manufacturing, Medical Affairs, Laboratories, Pharmacovigilance, Regulatory Affairs, Translational Medicine, vendors (CSPs) and partners in GMP QA). Experience with multiple IT programs and systems, including but not limited to Clinical Trial Management systems, eTMF, eCRFs, Microsoft Office (including above average Excel skills), quality workflow systems.
Associate Director, Quality Risk Specialist (GCP) Bristol-Myers Squibb CoAssociate Director, Quality Risk Specialist (GCP)New Brunswick, NJ$163,850–$198,543 / yearProject Management: Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines. The Associate Director, RBQM will mainly be responsible for developing the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end RBQM for critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk and issue management.
NewSenior Clinical Data Coordinator - Clinical Research Hackensack Meridian HealthSenior Clinical Data Coordinator - Clinical ResearchParamus, New JerseyFull timeOrganizes and prepares for all study related sponsor visits up including, but not limited to Pre-Site Initiation Visits, Site Initiation Visits, Routine Monitor Visits, Close-Out Visits, Internal Audits, and Sponsor Audits. Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Clinical Research Coordinators, Sponsors, Contract Research Organizations, and employees of Hackensack Meridian Health.
Clinical Research Coordinator - Clinical Education - Trenton - PER DIEM Capital HealthClinical Research Coordinator - Clinical Education - Trenton - PER DIEMPennington, NJ$86,964.80–$119,714.81 / yearWhen determining base salary and/or rate, several factors may be considered including, but not limited to location, years of relevant experience, education, credentials, negotiated contracts, budget, market data, and internal equity. Capital Health is a dynamic health care resource accredited by the DNV that includes two hospitals, an outpatient center, satellite ED, and an expansive network of primary and specialty care.
Senior Clinical Lead, Early Clinical & Experimental Therapeutics SanofiSenior Clinical Lead, Early Clinical & Experimental TherapeuticsMorristown, NJ$236,250–$393,750 / yearIn these roles, duties include: Design safe, rapid and informative First-In-Human studies for oncology assets potentially including natural history, experimental model validation, mechanistic and signal seeking, streamlined Proof-of-Mechanism as well as Proof-of-Concept studies providing robust data for early Go/No Go decisions and other pharmacokinetic studies. A key focus of this role is to support the path from the research phase through early clinical development including early and rapid Proof-of-Mechanism/Proof-of-Concept, as well as natural history studies and experimental model validation to contribute to Human Target Validation (HTV) and evaluating the pharmacology of novel therapeutic approaches.
Clinical Practice Coordinator - Clinical Education - Trenton - Full-Time - DAYS Capital HealthClinical Practice Coordinator - Clinical Education - Trenton - Full-Time - DAYSHopewell, New JerseyOccasional physical demands include: Standing, Climbing (e.g., stairs or ladders), Carry objects, Push/Pull, Twisting, Bending, Reaching forward, Reaching overhead, Squat/kneel/crawl, Taste or Smell. When determining base salary and/or rate, several factors may be considered including, but not limited to location, years of relevant experience, education, credentials, negotiated contracts, budget, market data, and internal equity.
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 Trials Registered Nurse, Clinical Research Trials, Full Time, Day The Valley HospitalClinical Trials Registered Nurse, Clinical Research Trials, Full Time, DayParamus, New JerseyTo coordinate and implement clinical research protocols under the direction of the Director of Oncology Clinical Trials and Research Compliance, provide care to all or some of the patient's enrolled in each protocol, act as the patient advocate by assuring the safety, consistency, and accuracy of the treatment regimen as dictated by the protocol, and coordinate all nursing activities specifically related to the implementation of the treatment regimen. Must demonstrate effective oral and written communication skills, including speech clarity, understanding the information relayed, deductive and inductive reasoning skills (the ability to apply general rules to specific problems to produce answers that make sense and the ability to combine pieces of information to/from general rules or conclusion respectively).
NewClinical Research Manager (CRM) Lead - Oncology/Early Development Merck & Co IncClinical Research Manager (CRM) Lead - Oncology/Early DevelopmentRahway, NJ$142,400–$224,100 / yearLeads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTCs, CRAs and COMs). Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
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.
Clinical Research Coordinator - Somerset, NJ IQVIAClinical Research Coordinator - Somerset, NJParsippany, New JerseyThis role plays a critical part in the successful execution of clinical trials, combining hands-on clinical procedures, patient interaction, and study coordination to ensure compliance, data integrity, and participant safety. By combining deep scientific expertise with cutting-edge technology, we deliver high-quality data and insights that accelerate innovation and improve patient outcomes worldwide.
Clinical Research Coordinator - Union, SC IQVIAClinical Research Coordinator - Union, SCParsippany, South CarolinaThe actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
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 II Iterative Scopes IncClinical Research Coordinator IIClifton, NJLead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies, with accountability for achieving enrollment goals. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Clinical Data Manager Terumo CorpClinical Data ManagerSomerset, NJ$70,500–$96,910 / yearThe Clinical Data Manager is responsible for the following activities: protocol review, CRF design and development, development of database specifications, development of edit check specifications, development of the Data Management Plan, development of CRF Completion Guidelines, User Acceptance Testing (UAT), data review, query generation and resolution, data reconciliation, identification and review of protocol deviations, review of adverse events, and maintenance of study documentation in the electronic Trial Master File (eTMF). The Clinical Data Manager works as an integral part of a cross-functional team throughout the lifecycle of the research study from design through final analysis and study closeout by collaborating with the project teams and providing data review, analytics, and reports.
Clinical Research Nurse Hackensack Meridian HealthClinical Research NurseParamus, 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.
NewClinical Research Coordinator Hackensack Meridian HealthClinical Research CoordinatorParamus, New JerseyFull timeSchedules, coordinates, prepares, and assists for all sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit; Meets with monitor at least once during each monitor site visit and resolves all issues found during visit. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.
Clinical Research Nurse - Per Diem Weekend Days Hackensack Meridian HealthClinical Research Nurse - Per Diem Weekend DaysHackensack, New JerseyPer diemResponsibilities: 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.
Clinical Research Nurse - F/T Days Hackensack Meridian HealthClinical Research Nurse - F/T DaysHackensack, 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.
Executive Director, Product Development Team Leader, Clinical Research, Hematology - Lymphoma Merck & Co IncExecutive Director, Product Development Team Leader, Clinical Research, Hematology - LymphomaRahway, NJ$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.