Vendor Outsourcing Manager LancesoftVendor Outsourcing ManagerParsippany, 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.
Project Manager Integrated Resources, IncProject ManagerSouth Plainfield, New JerseyFull timeResponsible for the success of the global drug development, manufacturing, clinical trials; coordinates the operational aspects of ongoing global clinical trials to ensure meeting all required timelines as well as adherence to budget, quality and performance expectations. • Serve as the primary study contact during trial conduct including, but not limited to, regular conferences calls and team meetings with appropriate functional areas, management and vendors as necessary.
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.
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).
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.
Category Manager Integrated Resources, IncCategory ManagerNewark, New JerseyContractorThe Category Manager II will be responsible for driving performance from the supply base and internal procurement team, which include competitive market analysis; supplier identification and relationship management; execution of the RFI/RFP and competitive bid process; contract and price negotiations; and the day to day management of assigned programs to drive savings, improve business processes and comply with all corporate, legal and regulatory policies. Strong current hands on knowledge and experience sourcing the full breath of Information Technology products and services, including, but not limited to, enterprise wide software, enterprise wide hardware, Off-Shore Application Development, Telecommunications, and Managed Services agreements.
Regarding Manager II, Enterprise BPI Position Integrated Resources, IncRegarding Manager II, Enterprise BPI PositionNewark, New JerseyFull timeJob Summary: The Manager II – Enterprise Business Process Improvement role is responsible for managing and motivating a staff of Implementation Managers and Delivery Managers to execute a portfolio consisting of cross-divisional and enterprise business process improvements initiatives focused on reducing cost and complexity across the enterprise. Additionally, the incumbent will interact with senior division leadership to develop BPI portfolios, quantifying the value, ensuring implementation, and monitoring results/sustaining results.
Business Process Improvement Manager Integrated Resources, IncBusiness Process Improvement ManagerNewark, New JerseyFull timeLeadership: • Experienced process improvement leader with a focus on driving enterprise initiatives, cost and complexity reduction, and institutionalizing Business Process Improvement learning • Direct complex process improvement initiatives affecting multiple functions or businesses • Serve as a dedicated resource working directly with senior division leaders and staff to support process improvement • Report and communicate the results from process improvement efforts to key stakeholders including C-suite executive and other senior leaders • Assist the Enterprise Directors in setting and executing BPI strategy • Build strong relationships to enhance collaboration between the BPI team and divisional staff • Manage and motivate BPI and divisional staff working on projects within a matrix reporting structure • Engage people and develop them through team work and a high level of participation • Assess change readiness and prepare plans for helping stakeholders through change • Utilize process improvement principles and tools to achieve significant improvement results • Direct the work and analyses of process improvement implementation managers, delivery managers and analysts • Drive for high quality, actionable results Process Improvement: •. • Utilize various process improvement tools and methodologies when designing BPI team's work plans to meet business objectives • Anticipate and proactively manage program risks and issues that impact program progress • Ensure timely completion and achievement of project deliverables • Deliver practical solutions and methodologies to solve complex business problems • Manage, coach, and mentor project teams • Develop and present internal and external content for leadership team • Ensure deployment of common solutions across divisions and businesses • Vet new project opportunities and write corresponding business cases • Develop and share best practices among fellow process improvement coaches and clients Financial Management: • Partner with Finance to develop and track project metrics • Partner with business stakeholders to identify and drive out excess costs • Monitor performance and improvement in key metrics • Deliver operational improvement and financial benefits to meet or exceed annual targets Education/Experience: • Requires a Bachelor's degree in an engineering, business, or technical discipline from an accredited college or university; Master's degree preferred • Requires a minimum of 12 years process-related experience •.
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.
Senior Clinical Study Manager Integrated Resources, IncSenior Clinical Study ManagerWoodcliff Lake, New JerseyFull timeCollaborate with other team members to coordinate the development and finalization of key study documents including protocols, case reports forms, informed consent documents, study management plans and final clinical study reports. Oversee Clinical Trial Coordinator for assigned project to ensure successful management of project(s), including development of the project plan, maintenance of trackers, and generation of metrics reports.
Senior Clinical Data Manager Integrated Resources, IncSenior Clinical Data ManagerWoodcliff Lake, New JerseyFull timeCoordinates and conducts setup activities, such as CRF design for complex trials, database structure design, CRF annotation, project document creation and/or approval, data entry screen design and testing, validation check creation, testing and approval. • Perform DM activities for in-house and outsourced trials: protocol review, CRF development, database set up activities, data validation process (including manual data review of listings), SAE reconciliation, managing local laboratory and external labs and database lock.
Clinical Data Manager Integrated Resources, IncClinical Data ManagerWoodcliff Lake, New JerseyFull timePerform DM activities for in-house and outsourced trials: protocol review, CRF development, database set up activities, data validation process (including manual data review of listings), SAE reconciliation, managing local laboratory and external labs and database lock. Bachelor degree or above in scientific or related field Minimum 5-7 years' experience in Data Management with experience in managing projects, project teams.
Clinical Supply Manager Integrated Resources, IncClinical Supply ManagerJersey City, New JerseyContractorA minimum of a Bachelor's Degree and 4 years of experience in clinical supplies or a related supply chain role (supply or demand planning) is required OR a minimum of 8 years of experience in clinical supplies or a related supply chain role is required. • A minimum of 2 years of experience in multi-disciplinary CSC or Pharma R&D areas (manufacturing, packaging & labeling, logistics, supply chain, clinical operations, pharma/bio research R&D, project management) is highly preferred.
Clinical 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 Development. The 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 Scientist Integrated Resources, IncClinical Research ScientistWoodcliff Lake, New JerseyContractorPrepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc). In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.).
Clinical 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. Demonstrated comprehensive experience in clinical research processes, FDA regulations and GCP/ICH guidelines.
Sr. Clinical Project Manager Integrated Resources, IncSr. Clinical Project ManagerSouth Plainfield, New JerseyContractorA 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. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Lead Clinical Research Associate Integrated Resources, IncLead Clinical Research AssociateRaritan, New JerseyFull timeResponsibilities: 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. • Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion.
Clinical Project Scientist Integrated Resources, IncClinical Project ScientistRaritan, New JerseyContractorScope of responsibility includes: In 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. The 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.
Sr.Clinical Data Manager Karwell TechnologiesSr.Clinical Data ManagerEdison, NJPerform or provide oversight to staff for all CDM activities from study startup to archival: design CRFs/eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHO Drug; and complete data base lock, archival, and closeout activities. Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures, CDASH and SDTM data formats.