Lead Clinical Data Manager Integrated Resources, IncLead Clinical Data ManagerLexington, MassachusettsContractorTakes 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. · Partnering with customers as a trusted consultant and becoming an integral part of customer's decision making Supports each clinical study and project team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines.
Sr. Clinical Research Program Manager Interstitial Lung Disease Brigham and Women's HospitalSr. Clinical Research Program Manager Interstitial Lung DiseaseBoston, MA$78,936–$128,928.80 / yearThe framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. ILD program RAs and research fellows are adequately documenting and completing their assigned work); development and implementation of patient recruitment/retention strategies and goals; and organization and completion of IRB and regulatory documents.
Clinical Research Coordinator Alcanza Clinical ResearchClinical Research CoordinatorRoslindale, MassachusettsScheduling subjects for study visits and conducts appointment reminders; Building/updating source as needed; Conducting monitoring visits and resolves issues as needed in a timely manner; Ensuring study related reports and patient results are reviewed by investigator in a timely manner; Filing SAE/Deviation reports to Sponsor and IRB as needed; Documenting and reporting adverse events; Reporting non-compliance to appropriate staff in timely manner; Maintaining positive and effective communication with clients and team members; Always practicing ALCOAC principles with all documentation; May assist with study recruitment, patient enrollment, and tracking as needed; Maintaining confidentiality of patients, customers and company information, and; Performing all other duties as requested or assigned. Responsibilities may include but are not limited to: Screening of patients for study enrollment; Patient consents; Patient follow-up visits; Documenting in source clinic charts; Entering data in EDC and answers queries; Obtaining vital signs and ECGs; May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Requesting and tracking medical record requests; Updating and maintaining logs, chart filings; Maintaining & ordering study specific supplies;].
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.
Lead Clinical Data Manager Katalyst Healthcares & Life SciencesLead 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.
Sr. Clinical Research Program Manager Interstitial Lung Disease Mass General BrighamSr. Clinical Research Program Manager Interstitial Lung DiseaseBoston, MassachusettsThe framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. ILD program RAs and research fellows are adequately documenting and completing their assigned work); development and implementation of patient recruitment/retention strategies and goals; and organization and completion of IRB and regulatory documents.
Senior Clinical Research Director SanofiSenior Clinical Research DirectorCambridge, MA$236,250–$393,750 / yearCollaborates with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. Collaborate with other CRDs within the project, ensure leadership, buildsconsensus, coordinate action plans with stakeholders to resolve project-related study issues, anticipate potential issues (sharing lessons learned) across the project or study teams.
Clinical Office Coordinator Adams ClinicalClinical Office CoordinatorWatertown, Massachusetts$22–$25.10 / hourServe as a primary point of contact for site communications, including front desk management, managing the main office phone line, triaging and routing voicemails, and internal updates to administrative and research teams. Demonstrate a strong sense of urgency in maintaining the safety of staff and participants by recognizing and responding appropriately to behavioral or safety concerns as the first point of contact, using de-escalation techniques in alignment with site protocols as needed.
NewClinical Research Coordinator II Iterative HealthClinical Research Coordinator IIProvidence, RIWe built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology. By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need.
Sr. Clinical Research Associate Getinge GroupSr. Clinical Research AssociateBoston, MAWith a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The Senior Clinical Research Associate will report to the VP Scientific and Medical Affairs and will play an important role in study data management and overall clinical operations of the prospective randomized studies.
Director, Clinical Data Management Stoke Therapeutics, Inc.Director, Clinical Data ManagementBedford, MA$225,000–$244,000 / yearRequired Skills & Experience: Bachelor's degree or higher in a scientific or healthcare discipline (advanced degree a plus), with 10+ years of progressive experience in data management within biotech, pharmaceutical, or CRO settings, including prior line-management / people leadership experience. In depth knowledge of clinical data management systems (eg: Medidata Rave Veeva Vault CDMS) required; working familiarity with data review, visualization, and analytics tools (e.g., SAS, R/Python, Spotfire, Power BI, J-Review, or elluminate).
Clinical Study Design Manager Science 37Clinical Study Design ManagerBoston, MAThe Clinical Study Design Manager is responsible for working with our clients and internal staff to define the eSource platform specification design for the study, including all data capture requirements, bridging the gap between protocol requirements and implementation. Experience in building and guiding organizational teams, leveraging each team member's unique background and perspective to achieve team goals while providing clear direction and accountabilities.
Lead Clinical Data Manager. Integrated Resources, IncLead Clinical Data Manager.Lexington, MassachusettsFull timeBuilding Authentic Relationships: Building trusting relationships that will enhance current and future needs Leads in developing trust through transparency in communication and individual actions; ensures outcomes are team driven rather than individually driven; promotes collaborative team and organizational success Key Skills, Abilities, and. 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.
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 Research Associate Alira HealthClinical Research AssociateFramingham, MassachusettsCRAs work closely with the In-house CRAs, Lead CRAs, Director of Clinical Monitoring and Project Managers to ensure sites’ protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
Senior Clinical Research Coordinator Beth Israel Lahey HealthSenior Clinical Research CoordinatorBoston, MassachusettsThis position is embedded within the BIDMC Clinical Research Coordinator Core, a centralized resource serving investigators across departments and divisions throughout the medical center, and operating in affiliation with the institution's Clinical Research Center, a member of Harvard Catalyst — Harvard's Clinical and Translational Science Center. Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving.
NewLead Clinical Study Manager 3316 Takeda Development Center AmericasLead Clinical Study ManagerMassachusettsIn partnership with data management, statistics and regulatory teams to review and provide input on all database timelines and plans, ensuring strong alignment between study data generation, database lock (DBL), and clinical study report (CSR) delivery; in accordance with overarching filing and registration strategies. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
Lead Clinical Study Manager (Lead CSM) 3316 Takeda Development Center AmericasLead Clinical Study Manager (Lead CSM)MassachusettsIn partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
Clinical Research Associate CRA Alira HealthClinical Research Associate CRABoston, MassachusettsThe CRA works closely with Lead CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. The CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality.
Clinical Research Coordinator Peregrine TeamClinical Research CoordinatorBoston, MAFull timePeregrine Team is seeking a Clinical Research Coordinator to support clinical trial operations for a leading pharmaceutical organization. Coordinate day-to-day clinical trial activities, including patient scheduling and follow-ups.