Lead Biostatistician (Interventional Cardiology and Vascular Research) Beth Israel Lahey HealthLead Biostatistician (Interventional Cardiology and Vascular Research)Boston, MassachusettsAdditional preferred qualifications include SAS Base and Advanced certification, hands-on experience working with SAS (Base, Stat, Macro, SQL), experience mentoring other statisticians and trainees in statistical methods, and expertise in at least one of the following areas: causal inference, longitudinal analysis, or weighting methods. Smith Center for Outcomes Research (bidmc.org)) is devoted to addressing the most pressing issues in cardiovascular care through innovative and rigorous analysis of diverse data sources, including large national registries, administrative claims data, survey-based data, and EHR data.
Sales Executive, Technical Clinical Solutions IQVIA Holdings IncSales Executive, Technical Clinical SolutionsBoston, MA$89,600–$249,600 / yearJob Profile Summary: This role is highly focused on driving sales and cultivating new business opportunities in the Northeast region, requiring expertise in hunting for new clients, identifying growth areas, and building long-term, profitable partnerships. The Sales Executive will work directly with BioTech and Pharma clients to provide value-added input on strategic issues, identify business development opportunities, cultivate executive-level relationships, and deliver tailored, technology-enabled clinical solutions.
NewExecutive Director, Clinical Science, Oncology, Genitourinary, Melanoma, and Women's Cancers Merck & Co IncExecutive Director, Clinical Science, Oncology, Genitourinary, Melanoma, and Women's CancersBoston, MA$255,800–$402,700 / yearRequired Skills: Advanced Analytics, Artificial Intelligence (AI), Clinical Development, Clinical Sciences, Cross-Functional Leadership, Executive Leadership, Global Clinical Studies, Innovation, Matrix Leadership, Oncology, Oncology Drug Development, Regulatory Submissions, Strategic Leadership, Talent Development. The Executive Director, Clinical Science is a senior leader within Oncology Clinical Development responsible for providing strategic, scientific, operational, and people leadership across a portfolio of oncology programs spanning multiple therapeutic areas (Genitourinary, Melanoma, and Women's Cancers) and stages of development.
NewExecutive Director, Clinical Science, Oncology, Hematology, Oncology Assets and Early Development Merck & Co IncExecutive Director, Clinical Science, Oncology, Hematology, Oncology Assets and Early DevelopmentBoston, MA$255,800–$402,700 / yearRequired Skills: Advanced Analytics, Artificial Intelligence (AI), Clinical Development, Clinical Sciences, Cross-Functional Leadership, Executive Leadership, Global Clinical Studies, Innovation, Matrix Leadership, Oncology, Oncology Drug Development, Regulatory Submissions, Strategic Leadership, Talent Development. The Executive Director, Clinical Science is a senior leader within Oncology Clinical Development responsible for providing strategic, scientific, operational, and people leadership across a portfolio of oncology programs spanning multiple therapeutic areas (Hematology, Oncology Assets and Early Development) and stages of development.
Navigator, Clinical Care Lowell General HospitalNavigator, Clinical CareBoston, MAConducts telephonic patient outreach for patients discharged from the inpatient setting, emergency department and skilled nursing facility to ensure transitions of care including follow-up appointments, prescriptions are filled, homecare services are set-up and to encourage early symptom management with PCP and Urgent Care with a goal of preventing a readmission. Supports support multiple areas of the Clinical Care and Operations Team by creating and distributing multiple patient activity reports and other patient-based reports including databases for referrals, plan based level of care authorizations, and out of network activity including emergency and inpatient encounters.
RN Clinical Coordinator University of Massachusetts Medical SchoolRN Clinical CoordinatorWestborough, MassachusettsUnder the general direction of the Associate Director, or designee, the Clinical Coordinator is responsible to develop, prioritize, and oversee staff activities specifically designed to promote the coordination of care for those MassHealth members who have medically complex, chronic or catastrophic illnesses that require a customized approach to how, when, and where they receive medically necessary health care services. 3 years of related work experience with prior authorization and/or eligibility determinations for disabled, medically complex, home care, rehab or long term care populations strongly preferred.
Medical DirectorScientific Director Neuroscience Clinical Development - Psychiatry AbbVie IncMedical DirectorScientific Director Neuroscience Clinical Development - PsychiatryWaltham, MAResponsibilities: With appropriate supervision, manages the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
NewExecutive Medical Director Oncology Clinical Development AbbVie IncExecutive Medical Director Oncology Clinical DevelopmentWaltham, MAActs as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Responsibilities: Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues.
Clinical & Translational Research Unit Lab Technician I Boston Children's HospitalClinical & Translational Research Unit Lab Technician IBoston, MAUnder direct supervision of the BCH Clinical & Translational Research Unit (CTRU) lab supervisor, the primary on-site lab technician lab handles, processes and manages specimens entering the CTRU lab from research participants throughout the institution. Completes assigned tasks such as assisting with monitoring and maintenance of lab equipment, lab-related inquiries, and Clinical Research Operations (CRO) Continuous Quality Improvement projects and lab sample tracking database.
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.9. 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.12.
Vice Chair of Research for Basic & Translational Sciences Boston Medical CenterVice Chair of Research for Basic & Translational SciencesBoston, MA$220,000–$450,000 / yearDepartment Overview: Located in Boston''s historic South End, the Department of Medicine at Boston University Chobanian & Avedisian School of Medicine and Boston Medical Center is renowned for its impact of teaching and research programs and state-of-the-art clinical care for patients. In close partnership with the Vice Chair of Research for Clinical and Implementation Sciences, this role will ensure alignment across the full research continuum-from bench to bedside to population health-while identifying emerging scientific opportunities and driving strategic investments in faculty, infrastructure, and technology.
Clinical Data Manager Integrated Resources, IncClinical Data ManagerCambridge, MassachusettsContractorReview study database design and derivations to ensure the database will meetReview study validations and/or edit checks to ensure the quality of the dataManage Analytical Sciences project plan, report on progress of Analytical Sciences deliverables, identify and resolve issues, coordinate activities with the project team and management for assigned compoundsAnticipate and communicate resource and quality issues that may impact deliverables or timelines for a program or group of studies. Represents DM function on major matters regarding policies, plans and objectives and industry meetings as well as serve as a role model and mentor and thought leader for DM.Actively mentors Data Managers and Senior Data Managers.
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.
Clinical Trials Safety Data Manager Integrated Resources, IncClinical Trials Safety Data ManagerCambridge, MassachusettsContractorConduct partner oversight and performance management on contracted work (e.g., monitoring reports, quality evaluations, annual meetings) Senior Manager, Safety Data Collection, Clinical Trials.• Communicates on PV legislation and regulatory commitments across the organization and externally Senior Manager, Safety Data Collection, Clinical Trials.• Acts as subject matter expert on Pharmacovigilance (PV) operations of Pre and Post-Marketing Clinical Studies during audits / inspections Senior Manager, Safety Data Collection, Clinical Trials. Report metrics and KPIs for Clinical Trial safety report collection Senior Manager, Safety Data Collection, Clinical Trials.• Oversee and ensure study safety operational requirements are operationalized Senior Manager, Safety Data Collection, Clinical Trials.• Support the following Strategic Partner / vendor oversight activities, in conjunction with relevant functions (such as Global Clinical Operations) in relation to Clinical Trial safety report collection.•
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 LeadOverseeing the tactical execution of the operational strategy by the partner CRO; effectively leads the study through oversight of the CRODriving performance, quality, timelines and relationships through the CRO partnership modelChairs 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 issuesPartnering with GCO Vendor Management to escalate issues, sharing best practices and leveraging the relevant vendor management member for issue resolution3. 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 groupSeeks interdependencies and synergies with other trials and programs to enhance superb planning and execution across all studies in a phaseFollows established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing modelEmbodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the new CRO partnership modelAt least 10 years of clinical research study management experience of which at least 4 years has been with a sponsor company managing outsourced clinical trials within quality, timeline, and budget expectations a plus.
NewSenior Clinical Trial Leader Kura OncologySenior Clinical Trial LeaderBoston, MA$182,000–$205,000 / yearKura developed and is commercializing KOMZIFTI® (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. General: Responsible for the planning and management of the operational aspects of clinical trials, including CRO and vendor management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are consistent with program/company goals.
Clinical operations Lead Integrated Resources, IncClinical operations LeadCambridge, MassachusettsContractor2. Support operational excellence and delivery for one or more clinical studies by: • Managing the study operational strategy (SOS) with guidance from the lead COL or COS • Providing input to operational strategy (including ancillary vendors) aligned with the program strategy and working closely with the Clinical Country Lead (CCL) to set the country strategy, incorporating country input through the primary COL and study CCL • Overseeing the tactical execution of the operational strategy by the partner CRO; effectively providing oversight of the CRO, including close monitoring of CRO work on established baseline plans, highlighting areas in need of focus to assure issues are raised and resolved so baselines can be achieved • Utilizing operational expertise and scientific assessment to evaluate study feasibility: assess end point measurement options, and ensure the successful execution of study(ies). • Overseeing delivery of the study to budget 3. Strives for effective, consistent, efficient and compliant processes by: • Participating in best practice development in Phase planning and seeking opportunities for innovation and efficiency with the Clinical Study Leadership group • Following established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing model; provides feedback via appropriate channels for opportunities to improve processes or set best practices (i.e. PON) • Embodying a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the CRO partnership model.
Senior Manager, Contracts - Clinical Nuvalent IncSenior Manager, Contracts - ClinicalCambridge, MA$155,000–$175,000 / yearQualifications: Minimum of 7 years of contracts experience in the biopharmaceutical or clinical research industry, with at least 4 years focused on vendor agreements, clinical site agreements, investigator agreements, or study start-up contracting; sponsor-side experience preferred, CRO-side experience considered. This is a hands-on, high-volume role responsible for the full lifecycle of clinical site agreements and ancillary clinical contracts across Nuvalents global study portfolio, currently spanning four concurrent studies including a Phase 3 randomized controlled trial.
Program Manager Brigham and Women's HospitalProgram ManagerBoston, MA$78,936–$128,928.80 / yearThe project includes an initial UG3 planning phase focused on protocol finalization, regulatory approvals, staff training, and site readiness, followed by a UH3 efficacy phase that will enroll 510 participants across five sites: Mass General Brigham, the University of Kentucky, Dell Medical School, Vanderbilt University, and Duke University. Be responsible for the day-to-day activities of assigning work projects, monitoring the progress of all project staff, and directly supervising and evaluating the work of the Project Coordinator and Clinical Research Coordinators (CRCs), including serving as back-up when needed.
Travel Sub-Investigator Care AccessTravel Sub-InvestigatorBoston, MARemote$130,000–$165,000 / yearWith programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Perform trial procedures as per delegation which can include the following but not limited to: Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment.