Quality Engineer Integrated Resources, IncQuality EngineerMansfield, MassachusettsContractorPosition Summary: · The PMV Data Manager is responsible for leading a group of PMV Data Analysts in developing statistically based ad hoc reports utilizing data generated by the Client complaint system to assist in the evaluation of safety triggers by PMV Analysts, providing leadership in the administration of the Client Complaint Tracking System (CTS) across the various Surgical Solutions Group sites, developing systems to provide support and tracking of ad hoc reporting outside the complaint group, as well as development and maintenance of the PMV SharePoint site. Location: Mansfield, MA Duration: 12+Months (Possibility of extension) Job Role: · This position is probably most closely associated with a Quality Systems Manager (IT oriented), with good program management skills.
Clinical Database Analyst Integrated Resources, IncClinical Database AnalystLexington, MassachusettsFull timePOSITION SUMMARY: Responsible for visualizing clinical trial data in SPOTFIRE for the Analytical Risk-based Monitoring (ARBM) group and for the medical reviewers in the iDARTs application (an internally developed tool for medical review of clinical trial data based on TIBCO's Spotfire). o Collect additional user requirements (from study physicians & data managers) and design new visualizations (Tables/Graphs).
Business Development Manager, Licensing - Waltham The Steely GroupBusiness Development Manager, Licensing - WalthamField-Based, Waltham, MAOur client is seeking a scientifically driven Business Development Manager to help identify and advance strategic licensing and partnership opportunities for its industry-leading antibody discovery platform. Working closely with cross-functional teams and external partners, you'll help evaluate new opportunities, support licensing initiatives, and contribute to the growth of the companys global partnerships.
Digital Marketing Project Manager Integrated Resources, IncDigital Marketing Project ManagerWeston, MassachusettsFull timeBe highly organized and work well under pressure - Be capable of working on multiple projects at once - Be able to work independently - Have strong familiarity with digital marketing and web content management processes and concepts - Have experience working with creative agencies and be familiar with creative agency work products (i.e. Photoshop files, manuscripts, wireframes). Skills Desired: - 5-7 years project management experience with web projects required - Proven track record of delivering projects on time and in budget - Pharmaceutical experience helpful - Have strong analytical and creative problem solving skills - Have excellent verbal and written communication skills.
PV Scientist Manager Integrated Resources, IncPV Scientist ManagerCambridge, MA$100–$110 / hourCollaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas. Contributes to activities related to the functioning of Client safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues.
Residential Manager BridgewellResidential ManagerPeabodyFull timeWhile performing the duties of this job, the employee is required to be able to: Climb stairs, physically assist people served, often weighing more than 200 pounds, with movement, bathroom routines including toileting, assisting with entry and exit of a tub or shower, getting into and out of wheelchairs or dealing with assists that include physical, behavioral and medical interventions. Demonstrate ability to drive a 12-passenger van and/or a wheelchair van Physical Demands: The physical demands of staff working in residential programs assisting people with their care needs are varied and require the employee to be able to maneuver people of varying weights, and provide lifting, balance support and physical intervention in several scenarios.
Project Manager Integrated Resources, IncProject ManagerLexington, MassachusettsContractorThe incumbent will thrive in an environment where priorities change daily, and where he/she wears many hats, is focused, detailed-oriented and thrives in a fast paced environment. 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.
Quality Manager Integrated Resources, IncQuality ManagerLexington, MassachusettsFull timeBS/MS in science related field or an engineering degree with having 6-8 years of Quality within risk methodology experience OR at least a member of the risk assessment team. • Analyzes data from various sources (including, but not limited to: Non-Conformances, CAPAs, Deviations, Complaints, etc.) to identify and initiate QRM opportunities.
Site Relationship Manager Integrated Resources, IncSite 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 analyses site activities and study conduct through on-site and remote assessments/contacts. Location: Cambridge, MA Duration: 12+ months (possibility of extension) JOB ROLE: · The Site Relationship Manager (SRM) within Value Based Medicine (VBM) will be responsible for the overall US site management, training and quality oversight of assigned studies.
Manager, Quality Control Consultant The Steely GroupManager, Quality Control ConsultantHybrid, Waltham, MAThe selected candidate will work collaboratively with Analytical Quality Control leaders to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs and Quality Assurance to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities. Contribute to regulatory and technical documentation by reviewing QC data for accuracy, completeness, and traceability; verifying data transcription and data checks supporting regulatory submissions; and ensuring information is ready for inclusion in internal reports, APQRs, Module 3 submission-supporting documents, and responses to regulatory authorities.
SALES OPERATIONS MANAGER Integrated Resources, IncSALES OPERATIONS MANAGERMarlborough, MassachusettsFull timeCreate and customize Objects, Workflows, Record Types, Page Layouts, Fields (including advanced formulas and lookups), Apps, Tabs, Profiles, Security, Users, and approval processes. Overview: Responsible for leading the performance reporting, analytical data modeling and insight, targeting and alignments, CRM development, and incentive compensation management for the commercial organization.
Sr Manager, Early Planning & Patient Recruitment Integrated Resources, IncSr Manager, Early Planning & Patient RecruitmentCambridge, MassachusettsContractorIntegrate EPR efforts with Client Advocacy to identify Patient Advocacy Groups who can provide patient/caregiver input/perspective on study design and study burden; develop methods to assess patient and site burden of schedule of assessments e.g., duration of visits, frequency of visits compared to SOC, questionnaire volume / survey fatigue, etc. · Identify & manage vendor(s) and develop process to support study teams regarding the assessment and incorporation of patient input into Client protocols to influence study design and early operational strategy with the goal of generating data to support executable, patient-friendly study designs and assessments.
Product Manager III - Global Downstream Marketing Gateway RecruitingProduct Manager III - Global Downstream MarketingBoston, MAThis role is ideal for a marketer with solid downstream experience who is ready to deepen functional expertise, drive cross-functional initiatives, and influence portfolio direction through data-driven insights, customer engagement, and strong execution. Lead the commercial execution of a key early-stage product launch, focused on driving initial market development, identifying and converting early adopters, and establishing clinical and procedural proof points.
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.
Technical Program Manager - Sr KYYBA, IncTechnical Program Manager - SrBoston, MAExperience designing, implementing, testing, or supporting healthcare technology and interoperability solutions, including cloud-hosted systems, HRE, EMS, HIEs, APIs, HL7/FHIR and EDI integrations, cybersecurity, telehealth, remote patient monitoring, data platforms, analytics, and reporting solutions. Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
Clinical Project Manager Integrated Resources, IncClinical Project ManagerLexington, MassachusettsContractorJob Position: Clinical Project Manager Location: Lexington, MA Duration: 6 Months+ (Temp to Perm) Summary: The Clinical Project Manager is responsible for independently managing a small number of studies of basic to moderate complexity or defined activities in more complex, multicenter studies (e.g., managing niche vendors). Our 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.
Clinical Project Manager III Integrated Resources, IncClinical Project Manager IIILexington, MassachusettsFull timeResponsibilities % of Time Job Function and Description 10 %: • Represents and leads the study team to design, develop and deliver the clinical study in accordance with the clinical development plan/strategy, budget and timeline • Authors/contributes to clinical study documents. Title: Clinical Project Manager III Location: Lexington, MA, United States Duration: 06+ Months Job Details: • Responsible for the planning, implementation, execution and management of one or more complex clinical research studies.
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.
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.
Clinical Study Manager Integrated Resources, IncClinical 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. 11 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.