Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & Governance Daiichi Sankyo, Inc.Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & GovernanceBasking Ridge, NJ$271,500–$452,500 / yearFull timeEnsure all key internal stakeholders are aligned on the approach and the conduct of a global studies/programs that will be implemented in multi-regions (US, Europe, ASCA, Japan)- including Regional Medical, Regional Operations, Safety, Regulatory, Quality, Legal/Compliance, Clinical Supply Operations, Global Program Teams, GMAT Leads, GMA leadership. Responsible for primary data evidence generation delivery of GMA programs: Company Initiated studies (CIS), Non-Interventional Studies (NIS) and Expanded Access Programs (EAP) delivery across countries in Oncology Business Unit and other Regions.
Director, Clinical Science Daiichi Sankyo, Inc.Director, Clinical ScienceBasking Ridge, NJ$201,840–$302,760 / yearFull timeProgram related: Integrated Study Team (IST) representative: Creates early development plan and contributes to overall development strategy; Contributes to development of program biomarker strategy; Achieves endorsement for plan by function and team; Interprets and react accordingly to new preclinical/clinical data(e.g. Participates in creation of developmental and regulatory strategies and prepares clinical sections of regulatory documents; acts as the Point of Contact for interactions with regulatory agencies related to clinical matters.
Associate 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 within Hematology, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Advanced Technical Expertise: Possess advanced understanding of pre-clinical and clinical research, including protocol writing, data review, study design, and disease area knowledge preferred.
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.
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.
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).
NewClinical Team Manager (RN), Hospice Home Care, Staten Island VNS HealthClinical Team Manager (RN), Hospice Home Care, Staten IslandStaten Island, NY$98,200–$130,800 / yearWe’re one of the largest nonprofit home- and community-based health care organizations in the country, and today, more than 11,500 team members work together to make a difference in the lives of more than 99,000 patients and members on any given day. Participates in Hospice Team meetings, IDG management meetings, and serves on relevant committees for the purposes of information exchange, team collaboration, development of procedures and documentation tools, development of quality and training.
Executive Director, US Medical Research & Strategy, Operations, and Engagement Daiichi Sankyo, Inc.Executive Director, US Medical Research & Strategy, Operations, and EngagementBasking Ridge, NJ$271,500–$452,500 / yearFull timeAdditionally, the Executive Director contributes to excellence in clinical research by developing strategies for lifecycle management, IIS programs and post approval clinical programs in consultation with commercial, development and outside experts, and by building the image of the company as a partner in research projects. Oversee a Medical Affairs oncology team that works alongside Oncology Field Medical Affairs for interactions with Key External Experts in Oncology including advisory boards, Congress activities, and investigator initiated studies, advocacy and sponsorships.
Clinical Trial Manager/Senior Clinical Trial Manager Precision Medicine Group LLCClinical Trial Manager/Senior Clinical Trial ManagerNY$110,700–$200,900 / yearThis compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.
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.
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 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).
Senior Clinical Research Manager BeOne Medicines AGSenior Clinical Research ManagerNY$136,400–$181,400 / yearLead and contribute to strategic initiatives and task forces aimed at improving clinical operations processes and outcomes, driving projects from inception to completion in alignment with organizational goals and in collaboration with cross-functional teams. General Description: The Senior Clinical Research Manager oversees clinical monitoring activities and the CRA team's performance to ensure they comply with ICH-GCP, local regulations, and company SOPs, and maintain quality across clinical trials.
Clinical Research Coordinator Frontage Clinical Services IncClinical Research CoordinatorSecaucus, NJ$50,000–$52,000 / yearThe Clinical Research Coordinator is required to perform study procedures, to generate, evaluate, review and record study data, to transcribe source data to case report forms, to liaise with sponsor personnel, to maintain a high level of professional expertise through familiarity with the study protocol, investigator's brochure, and related study materials, and to participate in project team meetings. Position/Job Summary: Responsible for working under the guidance of the Principal Investigator and Sub-Investigators, and Clinic Operations to participate in the planning, implementation and overall direction of clinical research trials conducted on behalf of sponsors at the Frontage Clinical Services, Inc.
Operations Director, Clinical Laboratory Operations - Clinical Laboratory Administration - Tri State Area (New York, New Jersey, Connecticut) - Full Time/Day Shift Mount Sinai Health SystemOperations Director, Clinical Laboratory Operations - Clinical Laboratory Administration - Tri State Area (New York, New Jersey, Connecticut) - Full Time/Day ShiftNewark, NJMount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology.
Clinical Research Specialist Operations Manager N-Power Medicine IncClinical Research Specialist Operations ManagerNYRemote$138,000–$160,000 / yearEducation, Experience, Behavioral Competencies, & Skills 5+ years of experience in healthcare operations, oncology clinical research, or health system-based programs 4+ years of people management or team leadership experience Bachelor's degree or equivalent professional experience Demonstrated experience with onboarding, training, and performance management Strong understanding of compliance and quality expectations in research settings Extensive familiarity and comfort with ambulatory oncology workflow Demonstrated success in building and leading high-performance teams, with the ability to inspire, mentor, and drive organizational change Collaborative, hands on manager who thrives in dynamic environments, with a strong desire to drive paradigm shifts in clinical research and improve patient outcomes Strong interpersonal skills with the ability to manage competing priorities in a fast-paced environment Exceptional written and verbal communication skills, with the ability to engage and influence senior stakeholders, clinical teams, and technical experts alike Generous, curious, and humble Preferred Ambulatory oncology clinic experience Experience managing teams distributed across multiple sites Familiarity with health system operations and stakeholder management Experience supporting regulated environments (clinical research, quality programs, patient services, etc.). Monitor workload distribution and staffing coverage across assigned sites Address routine performance issues and escalate as appropriately to the Associate Director Foster a positive, accountable, and highly engaged team culture Hiring, Onboarding & Training Execution Partner with the Senior Manager to support hiring needs Own rapid and effective onboarding for new team members Identify onboarding gaps and recommend improvements to training processes Staff Development & Performance Management Conduct regular check-ins and coaching with direct reports Support ongoing skill development and role readiness Participate in performance reviews and contribute to promotion or corrective action discussions Identify high potential staff and collaborate with the Senior Manager on growth opportunities Compliance & Quality Oversight monitor adherence to documentation and process workflows that support the company's priorities.
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 Laboratory Scientist Clinical Lab Prime Healthcare Services IncClinical Laboratory Scientist Clinical LabPassaic, NJEach individual performing the above procedures must: 1) adhere to the laboratorys procedures for the collection, processing, analysis, and reporting of patient test results, 2) follow the laboratorys established quality control policies and procedures in documenting all corrective actions taken when test systems deviate from the laboratorys established performance specifications, 3) be capable of identifying problems that may adversely affect test performance and either correct the problem or immediately notify your immediate supervisor, Director, or Medical Director, 4) perform a wide variety of laboratory procedures requiring independent judgment using both manual and automated methods in Hematology, Blood Bank, Chemistry, Urinalysis, Coagulation, Microbiology, Immunology, and any other discipline as introduced into the laboratory, 5) perform and document maintenance daily, weekly, monthly, or as needed on instruments and equipment as appropriate, 6) review the accuracy of patient results prior to releasing or reporting, 7) recognize age specific differences in expected results for newborns to geriatrics, 8) ensure that the testing of proficiency testing samples are tested in the same manner as patient samples and that collaboration with other laboratories is prohibited prior to the reporting of proficiency testing results to the appropriate agencies, 9) may be required to perform venipuncture or capillary puncture on various age groups from newborn to geriatrics, 10) assist in the development and maintenance of laboratory policies and procedures, 11) adheres to all department and hospital policies and procedures related to safety, infection control, emergency preparedness, and human resources, 12) 12) in the absence of a supervisor, may be assigned/identified as Lead Tech, having responsibility for the section or department during their shift, 13) may be assigned responsibilities related to LIS and/or POCT. The exact starting compensation to be offered will be determined at the time of selecting an applicant for hire, in which a wide range of factors will be considered, including but not limited to, skillset, years of applicable experience, education, credentials and licensure.
Senior Clinical Research Associate Protagonist TherapeuticsSenior Clinical Research AssociateNewark, New JerseySupport study vendor management by performing key activities as delegated by study CTM, including but not limited to: Participate in evaluation of new vendors (CROs, labs, central readers, EDC, etc.) by drafting and/or reviewing RFPs, analyzing responses and drafting work orders for select vendors • Manage the day to day interactions with select study vendor(s), such as a central or specialty lab including developing training materials, lab manuals and acting as first point of contact for issue and query escalation and resolution. Yes, up to 10% Core Responsibilities Overall Study Execution Part of the clinical study team and takes a lead on execution by performing key activities as delegated by the Clinical Study lead, including but not limited to: Develop and/or review key study operational documents (e.g., study reference manual, laboratory and pharmacy manuals, data management plan, query generation, monitoring plan; review site audit reports) •.