Business Analyst - Full time Integrated Resources, IncBusiness Analyst - Full timeParsippany-Troy Hills, New JerseyFull timeElicit requirements using interviews, document analysis, requirements workshops, storyboards, surveys, site visits, business process descriptions, use cases, scenarios, business analysis, competitive product analysis, task and workflow analysis, and/or viewpoints. • Analytical skills, to critically evaluate the information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, abstract up from low-level information to a more general understanding, distinguish presented user requests from the underlying true needs, and distinguish solution ideas from requirements.
Senior Bio statistician Integrated Resources, IncSenior Bio statisticianWoodcliff Lake, New JerseyFull timeWork with the project statistician and clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality. • Work closely with clinicians, programmers, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review.
Senior Biostatistician Integrated Resources, IncSenior BiostatisticianWoodcliff Lake, New JerseyContractorSenior Biostatistician Description: • Work closely with clinicians, programmers, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review. • Work with the project statistician and clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality.
Biostatistician Integrated Resources, IncBiostatisticianWoodcliff Lake, New JerseyFull timeWork with the project statistician and clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality. Work closely with clinicians, programmers, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review.
Senior Manager, Biostatistics Integrated Resources, IncSenior Manager, BiostatisticsWoodcliff Lake, New JerseyFull timeThe study statistician will be accountable for supporting protocol development and study initiation, developing SAP, TLG shells, specification of variable derivation, SQS plan and DMC charter, providing statistical and validation support for analysis datasets, statistical TLGs, performing and validating statistical analysis, independently reviewing CSRs and performing data interpretation, supporting preparation of inputs for regulatory documents, drafting responses to health authorities including execution of new analysis required for responses, and managing CROs. The Senior Manager, Biostatistics - Neuroscience will be expected to work independently with minimal supervision, serving as study statistician for clinical studies.
Sr. Contracts Manager Integrated Resources, IncSr. Contracts ManagerWoodcliff Lake, New JerseyFull timesite start-up, global monitoring, regulatory, study file management, safety, clinical data management, statistics, and clinical reporting) and across a varied service provider base (e.g. Implement, integrate, and maintain department central repository databases for contract tracking purposes, workload management, and metrics tracking.
Regulatory Affairs Manager Integrated Resources, IncRegulatory Affairs ManagerWoodcliff Lake, New JerseyFull timeCandidate should be comfortable working independently to create Health Authority correspondence (including request for Health Authority consultations), and attending specific project team meetings (such as Clinical Study Team Meetings) as the Regulatory Affairs Representative and providing guidance to project teams on all areas of pharmaceutical drug development (ICH, 21CFR). Manager, Global Regulatory Strategy (GRS) will be a forward-facing role, representing GRS on project teams and communicating strategic options, issues and risks to a broad range of Stakeholders in an end-to-end pharmaceutical business model (R&D through commercial).
Manager, Vendor Outsourcing Net2SourceManager, Vendor OutsourcingParsippany, NJ$64.75–$71.94 / hourManages the contract negotiation process across the entire life cycle including RFI, vendor identification, RFP, vendor selection decision, contracting negotiation, performance monitoring, change orders, and ensures proper closeout of agreements to maximize contract value and achieve target savings. Communication Excellent communication skills and comfort level interacting with internal and external teams across all levels, including regular interface with stakeholders and leadership team members.
Vendor Outsourcing Manager LanceSoft IncVendor Outsourcing ManagerParsippany, NJ$71.94 / hourManages the contract negotiation process across the entire life cycle including RFI, vendor identification, RFP, vendor selection decision, contracting negotiation, performance monitoring, change orders, and ensures proper closeout of agreements to maximize contract value and achieve target savings. " Excellent communication skills and comfort level interacting with internal and external teams across all levels, including regular interface with stakeholders and leadership team members.
NewSenior GCP Auditor (Good Clinical Practice Quality Assurance) Macpower Digital Assets Edge Private LimitedSenior GCP Auditor (Good Clinical Practice Quality Assurance)Paramus, NJ$48–$53 / hourJob Summary: This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company's compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance Must Have: Bachelor's degree in a scientific, health care, or related discipline .
Clinical Lead - Sullivan Children's Home of Wyoming ConferenceClinical Lead - SullivanMonticello, NYFull timeThe Clinical Supervisor ensures timely crisis intervention in alignment with state and federal regulations and maintains consistent communication with families, providers, and external stakeholders such as health home care managers and DSS representatives. The supervisor provides clinical oversight, including fulfilling supervisory requirements for Other Licensed Practitioners (OLPs - Social Workers) and Community-Based Providers (CBPs), and offering psychoeducation on therapeutic interventions.
Clinical Lead - Orange Children's Home of Wyoming ConferenceClinical Lead - OrangeGoshen, NYFull timeThe Clinical Supervisor ensures timely crisis intervention in alignment with state and federal regulations and maintains consistent communication with families, providers, and external stakeholders such as health home care managers and DSS representatives. The supervisor provides clinical oversight, including fulfilling supervisory requirements for Other Licensed Practitioners (OLPs - Social Workers) and Community-Based Providers (CBPs), and offering psychoeducation on therapeutic interventions.
Manager, Clinical Contracts & Finance - III* MindlanceManager, Clinical Contracts & Finance - III*Parsippany, NJManages the contract negotiation process across the entire life cycle including RFI, vendor identification, RFP, vendor selection decision, contracting negotiation, performance monitoring, change orders, and ensures proper closeout of agreements to maximize contract value and achieve target savings. " Excellent communication skills and comfort level interacting with internal and external teams across all levels, including regular interface with stakeholders and leadership team members.
RN Clinical Liaison Journey HospiceRN Clinical LiaisonWest Caldwell, NJ$90,000–$100,000 / yearThe Clinical Liaison promotes Journey Hospice to the community, local hospitals, medical centers, physicians, case managers, social workers and other healthcare professionals to maintain a healthy census in the skilled nursing community. Assists the Marketing Department in promoting Journey Hospice to the community to the local area through participation on local boards, community groups, neighborhood block associations, and other organizations.
Physician Assistant - Medical Oncology and Clinical Trials Tal HealthcarePhysician Assistant - Medical Oncology and Clinical TrialsBronx, NY$180,000Youll care for oncology patients enrolled in early-phase trials in a low daily volume, high-touch outpatient environment, working closely with physicians and a well-structured research team. Our client a leading healthcare institution dedicated to advancing cancer treatment and research is hiring a Physician Assistant to join their distinguished team at the outpatient cancer center in New York.
NewSpec 3, Clinical Research MillenniumSoft IncSpec 3, Clinical ResearchFranklin Lakes, NJWorks with many different disciplines (manufacturing, marketing, quality, regulatory, etc.), materials, products and processes in the development of core clinical laboratory and outside the core clinical laboratory products and services. This position will also provide support to guide and implement innovation, product development, clinical testing, manufacturing, and post market surveillance via interfacing with R&D and GCD to insure successful and timely completion of projects.
Clinical Research Project Manager iMPact Business GroupClinical Research Project ManagerMahwah, NJLeading people who perform project management duties involving cross-functional teams focused on delivering internal products or administrative systems. Organizing project activities and interdepartmental meetings, ensuring communication facilitates the completion of the program or project on schedule and within budget constraints.
Clinical Trial Associate Integrated Resources, IncClinical Trial AssociateWoodcliff Lake, New JerseyContractorOur methods include applying domain expertise in specific industry segments, utilizing a highly-skilled workforce, leveraging a proven global delivery model, implementing structured and scalable quality processes and methodologies and yet, staying cost-effective. Job Title: Clinical Trials Disclosure Associate Duration: 1 year+ Location: Woodcliff Lake, NJ The Clinical Disclosure Associate will work across multiple disciplines within and outside Regulatory Affairs to drive departmental and project objectives.
Clinical Imaging Specialist Integrated Resources, IncClinical Imaging SpecialistWoodcliff Lake, New JerseyContractorDescription of Required Skill Set: Scientific background with understanding of clinical development and drug development process together with a broad understanding and experience of clinical operations or data management with clinical trials using medical imaging. Experience in oversight and management of imaging CROs, to ensure successful conduct of the imaging aspects of clinical trials ensuring data integrity and quality.
Clinical Bench Scientist Integrated Resources, IncClinical Bench ScientistPearl River, New YorkContractorResponsibilities: Generation and characterization of reagents, performance of experiments for development and qualification of assays, assay throughput for the pre-clinical studies and writing related procedures and reports. The position requires analyst participation in development and qualification of diagnostic ligand-binding assays for candidate and post-market vaccines in support of various programs.