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 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;].
Lead Clinical Data Manager Katalyst Healthcares & Life SciencesLead Clinical Data ManagerBoston, 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 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).
NewManager, Pre‑Clinical & Clinical Compliance Johnson & JohnsonManager, Pre‑Clinical & Clinical ComplianceRaynham, MA$102,000–$177,100 / yearIn the role as Clinical and Pre-Clinical QA Compliance Manager, GCP Quality activities include GCP Clinical and GLP Preclinical audits will include the following: Preparation prior to the audit, connecting with the clinical research team identified and providing advanced notice including securing availability to conduct the audit. For the DePuy Synthes organization, the Clinical and Pre-Clinical QA Compliance Manager main job responsibilities include conducting internal and external GCP Clinical Quality Assurance (QA) audits which include system, program and clinical site investigator sites as well as GLP Preclinical Quality Assurance Supplier Audits.
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.
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.
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.
NewClinical Regulatory Specialist Iterative HealthClinical Regulatory SpecialistCambridge, MAYou will collaborate with site teams, internal stakeholders, sponsors, CROs, IRBs, and other external partners to ensure regulatory requirements are completed accurately, efficiently, and in accordance with applicable guidelines and study requirements. Working under the direction of a Clinical Regulatory Manager Director, you will partner closely with clinical research sites to manage regulatory activities throughout the study lifecycle—from study start-up and activation through ongoing maintenance and closeout.
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.
Senior Clinical Studies Associate DeephealthSenior Clinical Studies AssociateSomerville, Massachusetts$71,000–$96,000 / yearFull timeWorking under the guidance of Clinical Study Manager and cross-functional study teams, the SCSA contributes to study operations, documentation, regulatory compliance, and process improvement initiatives. This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking.
Clinical Research Director SanofiClinical Research DirectorCambridge, MA$206,250–$343,750 / yearParticipates and contributes to regulatory and safety documents and discussions: Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
Clinical Research Coordinator Peregrine TeamClinical Research CoordinatorBoston, MAPeregrine 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.
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.
Manager, Clinical Science Relay Therapeutics, Inc.Manager, Clinical ScienceCambridge, MASupport Medical Lead to monitor real time study data to ensure the integrity of the study and the study data and working closely with clinical operations team to answer protocol related questions and resolve any study conduct issues from investigative sites. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology.
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 Study Design Manager Science 37Clinical Study Design ManagerBoston, MAThe following qualifications are preferred and/or equivalent applicable experience: Required: 3+ years of experience in clinical research or life science industry, including at least 3 years in design of CRF/ePRO or other clinical trials database capture software. The 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.
Senior Clinical Data Manager (Remote - US) MMSSenior Clinical Data Manager (Remote - US)Boston, MARemoteFull timeProvides oversight and resolves all issues in data management study processing activities including CRF tracking and data entry, integration of external electronic data (e.g., lab data) with clinical database, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits. Oversees and develops data management study documentation including Case Report Forms, CRF Completion Guidelines, Database Design via annotated CRFs, Validation specifications (edit checks), and Data Management Plan.
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.