Lead Clinical Data Manager Karwell TechnologiesLead Clinical Data ManagerCambridge, MACollaborate with cross-functional teams including Biostatistics, Clinical Operations, Safety, and Regulatory to ensure alignment of data management strategies with overall clinical development goals. Develop and implement data management plans, case report forms (CRFs), edit checks, and data validation plans in alignment with study protocols and regulatory requirements.
Clinical Site Relationship Manager Integrated Resources, IncClinical Site Relationship ManagerCambridge, MassachusettsContractorAssures ongoing site compliance with the protocols, informed consent process and documentation, as well as applicable FDA regulations and/or ICH GCP Guidelines and other local regulations critically reviews and analyzes site activities and study conduct through on-site and remote assessments/contacts. Responsible for development of study monitoring and management documentation and tools as delegated by the sponsor, including: Clinical Monitoring Plan, SIV slides, Regulatory Binder, Study Reference Guide, site tools, etc.
Director of Clinical Quality Integrated Resources, IncDirector of Clinical QualityCambridge, MassachusettsContractorJob Description: Job Title: Director, Vaccines Clinical Compound Support Quality Assurance OBJECTIVES: Plays a leadership role in ensuring that investigator, vendor, facility and system audits are conducted, for communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are implemented. Collaborates with the R&D QA, and other global entities to provide a consistent quality approach, including: Develops and presents periodic reports for assigned project describing VBU compliance trends and identifying areas of potential risk to VBU senior management.
Lead Clinical Data Manager Integrated Resources, IncLead Clinical Data ManagerLexington, MassachusettsFull timeProvides status reports/updates, resolves disputes, and ensures timely acquisition of high quality deliverables from the CRO Provides Data Management expertise to the team in identifying opportunities for process and budgetary optimization Coordinates with Biostatistics and Statistical Programming to ensure appropriate design, documentation. • Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve Contributes to regular budget forecasting and regular cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve results Courage to challenge.
Clinical Systems Business Analyst Integrated Resources, IncClinical Systems Business AnalystLexington, MassachusettsFull timeJob Description: • Provide support within Clinical and other groups as required relating to company's Clinical Trials Management System (CTMS) to support Clinical business process, including design of reports to meet organizational needs, serving as CTMS Administrator, super-user and technical support. • Facilitation of Clinical internal communication and support of external communication of Clinical structure, functions, partnerships, initiatives, and accomplishments to R&D by providing reports and metrics.
Sr. Clinical Study Manager Integrated Resources, IncSr. Clinical Study ManagerCambridge, MassachusettsFull timeProvides Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock, writing the Clinical Study Report. In collaboration with Study Execution Team (functions, Strategic Partners, and vendors), identify risks to study and suggest risk mitigation plans, with oversight of Clinical Program Manager and Associate Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning.
Clinical Program Scientist Integrated Resources, IncClinical Program ScientistLexington, MassachusettsContractorLeads cross functional teams and is responsible for the oversight and management of study timelines as well as the financial management of a study. Ability to manage and communicate effectively with research vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints.
IT Quality Analyst for Commercial Applications -GAMP 5- ANALYST - CONTRACT OPPORTUNITY Integrated Resources, IncIT Quality Analyst for Commercial Applications -GAMP 5- ANALYST - CONTRACT OPPORTUNITYWeston, MassachusettsContractorGENERAL SUMMARY: As a member of the IT Quality & Regulatory Compliance team, the IT Quality Analyst for Commercial Applications helps to define, plan, and perform duties that support major system development life cycle activities, including validation review and change control approval of IT Commercial systems. We have been honored by the following: Top 100 Diversity Owned Business in NJ for 2007, 2008 and 2009 Top 500 Privately-Held Business in the US Top 500 Diversity Owned Business in the US Top 100 Subcontinent Asian American Business in the US We have also been listed to the Inc.
Purchases/Sourcing Specialist Integrated Resources, IncPurchases/Sourcing SpecialistRaynham, MassachusettsContractorThe Strategic Sourcing Specialist will assist with finished goods and process selection for purchases, assist in locating and selecting suppliers for purchases per category strategies, negotiate prices, develop and administer contracts for assigned suppliers, develop suppliers, develop and improve large spend category strategies and major business processes such as business continuity and supplier selection to deliver annual improvements in total cost, quality and service, and support sites as needed. The Strategic Sourcing Specialist will support category development, sourcing of finished goods and supplier relationship management for assigned areas of responsibility.
Medical Writer - I Integrated Resources, IncMedical Writer - IRaynham, MassachusettsContractorOverview: The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the Client Strategic Medical Affairs Team for a wide range of audiences. Ability to understand and interpret statistical results of clinical studies; specifically summarize complex results and present them in clear, concise, and scientifically accurate manner to various end users.
Sr. Medical Writer Integrated Resources, IncSr. Medical WriterMansfield, MassachusettsRemoteFull timeMust be highly proficient in the use of Microsoft Office suite (especially Microsoft Word and PowerPoint); skill in Microsoft Excel, Photoshop, Illustrator, EndNote Reference Software, and other scientific graphics software would be helpful. Ability to understand and interpret statistical results of clinical studies; ability to summarize complex results and present them in a clear, concise, and scientifically accurate manner to a wide range of audiences.
Senior Clinical Study Manager Integrated Resources, IncSenior Clinical Study ManagerCambridge, MassachusettsFull timeProvides Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock, writing the Clinical Study Report. In collaboration with Study Execution Team (Takeda functions, Strategic Partners, and vendors), identify risks to study and develop risk mitigation plans, including communication and collaboration with Clinical Program Manager and Associate Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning.
Medical Writer Integrated Resources, IncMedical WriterMassachusettsContractorPosition Title: Medical Writing Specialist Division: Strategic Medical Affairs Reports To: Medical Safety Project Manager Job Function Summary The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the DePuy Synthes Strategic Medical Affairs Team for a wide range of audiences. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
Clinical Operations Lead Integrated Resources, IncClinical Operations LeadCambridge, MassachusettsContractorSecures operational excellence and delivery for one or more clinical studies by: • Developing operational strategy (including ancillary vendors) aligned with the program strategy and incorporating country input through the study Clinical Country Lead • Overseeing the tactical execution of the operational strategy by the partner CRO; effectively leads the study through oversight of the CRO • Driving performance, quality, timelines and relationships through the CRO partnership model • Chairs the [Study Management Team] in partnership with the CRO study Lead of the [Study Management Team]; ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues. Strives for effective, consistent, efficient and compliant processes by: • Championing best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management group • Seeks interdependencies and synergies with other trials and programs to enhance superb planning and execution across all studies in a phase • Follows established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing model • Embodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the new CRO partnership model.
Administrative Assistant Integrated Resources, IncAdministrative AssistantLexington, MassachusettsFull timePerforms more complex administrative activities including answering phones, managing email, managing budget and processing invoices and organizing our file room (may involve lifting some bankers boxes). • Has intermediate to advanced computer skills including: word processing, excel spreadsheet a must for invoices, presentations, booking travel and contract database.
Testing Assistant Integrated Resources, IncTesting AssistantBedford, MassachusettsContractorWorks in clean rooms, general lab, autoclave and cold room ranging from 2 to minus 8 degrees Celsius, where specified PPE for each area is required. Education/Experience: · Associate degree with 1-3 years' experience preferable in Biotechnology and or working in a laboratory or life sciences environment.
Sr. Administrative Assistant Integrated Resources, IncSr. Administrative AssistantLexington, MassachusettsFull timeHas intermediate to advanced computer skills including: word processing, spreadsheet, presentation, desktop publishing, database and/or project management applications. A 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.
Senior Administrative Assistant Integrated Resources, IncSenior Administrative AssistantLexington, MassachusettsContractormanaging projects, composing letters and reports, preparing/editing presentations, recommending or making purchase decisions, managing budget and payroll, and developing newsletters. Has intermediate to advanced computer skills including: word processing, spreadsheet, presentation, desktop publishing, database and/or project management applications.
Drug Safety Assistant Integrated Resources, IncDrug Safety AssistantSomerville, MassachusettsContractorRESPONSIBILITIES: Monitor and manage dedicated DSU mailboxes; Maintain local documentation as required by legislation (including archiving/tracking/retrieval) – lifting of boxes; Support the submission and distribution of reports and relevant tracking Support distribution and tracking of distribution of Follow-Up letters; Support inspection preparedness activities policies and practices as per Company SOPs; Consistently apply Archiving policies as per Company SOP. We have been honored by the following: Top 100 Diversity Owned Business in NJ for 2007, 2008 and 2009 Top 500 Privately-Held Business in the US Top 500 Diversity Owned Business in the US Top 100 Subcontinent Asian American Business in the US We have also been listed to the Inc.
Administrator Assistant Position Integrated Resources, IncAdministrator Assistant PositionLexington, MassachusettsContractorPerforms more complex administrative activities including managing projects, composing letters and reports, preparing/editing presentations, recommending or making purchase decisions, managing budget and payroll, and developing newsletters. Has intermediate to advanced computer skills including: word processing, spreadsheet, presentation, desktop publishing, database and/or project management applications.