NewRegulatory Coordinator - Neely Center For Clinical Cancer Research Tufts MedicineRegulatory Coordinator - Neely Center For Clinical Cancer ResearchBoston, MA$21.53–$26.91 / hourIn addition, this role focuses on performing the following Administration Project Management duties: Serves as a liaison between the general project management office and the team members engaging in planning, reviews the status of projects and budgets, manages schedules, prepares status reports, and assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction. Works collaboratively with a variety of personnel at all levels, including faculty and study team members of the Neely Center for Cancer Clinical Research (NCCCR) and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations.
Manager, 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.
Clinical 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.
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.
Senior Manager- Knowledge Management for Clinical Affairs Integrated Resources, IncSenior Manager- Knowledge Management for Clinical AffairsCambridge, MassachusettsContractorResponsibilities: Gathering end user requirements from key stakeholders and review of technical specifications for information governance in partnership with IT, maintaining of critical functionality of the CRM platform to ensure uninterrupted access by HCPs to company product information; Creation and maintenance of all metrics and analytic tools necessary for supporting GMA decision making and maintenance of the content management system used by Worldwide Medical. Advanced computer skills and experience in Sales force, web based inquiry database like Service Cloud, Veeva products like Vault, Tableau, Microsoft Office Suite software, and Endnotes software.
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.
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.
NewSenior Manager, Clinical Data Management BioNTech SESenior Manager, Clinical Data ManagementCambridge, MAA good match: University degree in natural/life sciences or equivalent experience in Clinical Data Management within CRO/biotechnology/pharmaceutical settings with 7-10 years of experience in Clinical Data Management, Profound knowledge of international guidelines (ICH-GCP) for clinical research projects. Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world.
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, 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.
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.
Sr. Manager/Associate Director, Clinical Monitoring Oversight Aura Biosciences Inc.Sr. Manager/Associate Director, Clinical Monitoring OversightBoston, MA$150,000–$215,000 / yearThis role is responsible for the strategic oversight of Clinical Research Associates (CRAs) and/or monitoring vendors (CROs), driving site performance, data quality, patient safety, and inspection readiness across all regions in which the trial(s) are conducted. Minimum 7-10 years of clinical research experience, including significant on-site or remote monitoring experience (CRA/Senior CRA background strongly preferred); typically, 3+ years in a lead CRA, monitoring management, or comparable oversight role for AD-level.
NewClinical Research Coordinator II UMass Chan Medical SchoolClinical Research Coordinator IIWorcester, MATrack and maintain study related information in the data management system within the required timeframe Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIs. This work includes coordination of regulatory activities and aspects of collection and management of data for complex research protocols related to treatment, ancillary services, and prevention practices.
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.
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.
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.
NewClinical Research Coordinator I Brigham and Women's HospitalClinical Research Coordinator IBoston, MA$20.16–$29.01 / hourHe/she/they will be responsible for patient scheduling and recruitment as well as all subject-oriented study procedures, such as administration of psychiatric scales, careful monitoring of adverse events, administrative duties related to the careful operation of study protocol, and database management and quality assurance. Our mission is to: (1) foster collaborative partnerships across sectors; (2) build school capacity to support student behavioral health; (3) uplift innovative, research informed prevention and intervention models; and (4) translate research into sustainable, scalable practice and policy.
Clinical Trial Associate Candel TherapeuticsClinical Trial AssociateNeedham, MA$88,000–$100,000 / yearThis role includes working on multiple protocols with the potential to cross-train across different oncology indications using a variety of clinical trial databases. Our Science: Advancing Cancer Immunotherapies Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses.
NewClinical Trials Project Manager CareerscapeClinical Trials Project ManagerBoston, MA$95,000–$125,000 / yearContractorOur client, a biopharmaceutical company based in Boston, is seeking a Clinical Trials Project Manager to oversee the execution of Phase II and Phase III clinical studies. This is a hybrid contract role based in Boston, with on-site presence required for study team meetings, site initiation visits, and sponsor audits.
Clinical Trial Manager BiogenClinical Trial ManagerCambridge, MassachusettsWorking closely with cross-functional partners, study sites, and external vendors, you will manage the day-to-day operations of clinical trials, tracking progress and identifying risks. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.