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.
Post-Doctoral Research Fellow - HBV Biomarkers and Liquid Biopsy Brigham and Women's HospitalPost-Doctoral Research Fellow - HBV Biomarkers and Liquid BiopsyBoston, MA$70,000–$71,750 / yearA Postdoctoral Research Fellow position is available at Massachusetts General Hospital and Harvard Medical School to support a research project focused on the development and clinical validation of blood-based biomarkers for early detection and monitoring of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B virus (HBV) infection. This project involves analysis of tumor-derived HBV-host junction sequences (HBV-JS) using next-generation sequencing (NGS), quantitative PCR (qPCR), and integration of molecular data with clinical and imaging datasets.
Research Community Health Worker Brigham and Women's HospitalResearch Community Health WorkerBoston, MA$23.51–$26.58 / hourResponsible for working closely with caregivers and healthcare providers to ensure a seamless and person-centered experience by assisting with navigating the complexities of the healthcare system, building psychosocial skills, and providing support to improve caregiver and patient outcomes. This position will support an American Society of Clinical Oncology (ASCO)-funded research project focused on the refinement and pilot testing of a behavioral coaching program for caregivers of patients with cancer, with a particular focus on liver cancer.
Senior Manager- Knowledge Management for Clinical Affairs Integrated Resources, IncSenior Manager- Knowledge Management for Clinical AffairsCambridge, MassachusettsContractorJob DescriptionJob Title: Senior Manager – Knowledge Management for Medical AffairsDuration: 14+ MonthsLocation: Cambridge, MAResponsibilities: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. Project management expertise with focus on driving for results and sense of urgencyMinimum of 7-10 years clinical data systems experience working in the biotechnology or pharmaceutical industryExperience applying best practices in application development to the clinical trial environment, including requirements definition and QC plansAware of current global regulatory guidelines relevant to Clinical Data Management, as well as related Pharma Development SOPs, guidelines and Best Practices.
Fire & Life Safety Officer Brigham and Women's HospitalFire & Life Safety OfficerBoston, MAThe incumbent's knowledge, skills, and experience in the field of safety and strong interpersonal skills will be utilized to provide in-depth technical and program support over a wide range of department functions, with an emphasis on proactively eliminating hazards in the hospital and laboratory environment. The 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.
Post-Doctoral Research Fellow - HBV Biomarkers And Liquid Biopsy Brigham and Women's HospitalPost-Doctoral Research Fellow - HBV Biomarkers And Liquid BiopsyBoston, MA$70,000–$71,750 / yearA Postdoctoral Research Fellow position is available at Massachusetts General Hospital and Harvard Medical School to support a research project focused on the development and clinical validation of blood-based biomarkers for early detection and monitoring of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B virus (HBV) infection. This project involves analysis of tumor-derived HBV-host junction sequences (HBV-JS) using next-generation sequencing (NGS), quantitative PCR (qPCR), and integration of molecular data with clinical and imaging datasets.
Travel Licensed Clinical Social Worker (LCSW) in Canton, MA TalentBurst Inc.Travel Licensed Clinical Social Worker (LCSW) in Canton, MACanton, MAAND A current and valid licensure as a Licensed Social Work Associate, Licensed Social Worker, Licensed Certified Social Worker, or Licensed Independent Clinical Social Worker issued by the Massachusetts Board of Registration. Supports patient discharge activities, beginning on the day of admission, through caregiver education on the transition process, identification of patient discharge options, and coordination with community providers to ensure continuity of care.
NewClinical Development Scientist Oncology Astellas Pharma IncClinical Development Scientist OncologyCambridge, MAResponsibilities and Accountabilities: Responsible and accountable for activities related to all current and planned clinical trials on assigned development programs (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting). Serves as key partner for the Development Division in assessment of candidates within discovery, identifying opportunities and potential risks in the context of future development strategies based on modality, indication, unmet need, competitive landscape, and clinical characteristics.
NewSenior Local Trial Manager (Sponsor Dedicated, Multiple Therapeutics) IQVIA Holdings IncSenior Local Trial Manager (Sponsor Dedicated, Multiple Therapeutics)Boston, MA$93,100–$232,800 / yearEnsures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing strategic input to study-level documents and independently leading/coordinating local team activities in compliance with SOPs, other procedural documents, and applicable regulations. Ensures Inspection Readiness by maintaining complete, accurate, and timely data and essential documents in systems utilized for trial management (e.g., CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements.
Director, Regulatory Affairs - Clinical Strategy Azurity PharmaceuticalsDirector, Regulatory Affairs - Clinical StrategyWoburn, MAPrinciple Responsibilities: Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements. Brief team/department description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director- Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications.
Clinical Documentation Improvement Specialist Lahey Hospital and Medical CenterClinical Documentation Improvement SpecialistMA$102,000–$158,392 / yearCritical Care and/or Emergency Nursing experience required Skills, Knowledge & Abilities: Proficient skill in query writing to physicians Knowledge to accurately complete chart audits Organizational and critical thinking skills required Experience with computer systems required, including web-based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint, or Access Pay Range: $102,000.00 USD - $158,392.00 USD The pay range listed for this position is the annual base salary range the organization reasonably and in good faith expects to pay for this position at this time. The Clinical Documentation Improvement (CDI) Specialist II assists with the appropriate identification of diagnoses, conditions, and/or procedures that are representative of the patients hospital stay and care provided including Severity of Illness (SOI), Risk of Morality (ROM), during an inpatient hospitalization.
Provider Clinical Operations Consultant, Senior Associate PricewaterhouseCoopers LLPProvider Clinical Operations Consultant, Senior AssociateBoston, MA$77,000–$202,000 / yearPreference for at least one of the following fields of study: Accounting, Actuarial Science, Analytics/Data Science, Business Administration/Management, Computer Science/Information Systems, Economics, Engineering, Finance, Government/Public Policy, Health Administration/Public Health, Mathematics/Statistics, Operations/Supply Chain, Organizational Management/Behavior, Risk Management/Insurance. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy .
NewJunior Clinical Operations Associate (College Grad 2027) Find Solace IncJunior Clinical Operations Associate (College Grad 2027)Boston, MASolace cuts through the red tape of healthcare by pairing patients with expert advocates and giving them the tools to make better decisions-and get better outcomes. Clinical or healthcare interest is a significant plus-itll help you understand context faster and build better systems, but we care more about operational chops than clinical credentials.
Program Manager - Gene Editing & Therapy Brigham and Women's HospitalProgram Manager - Gene Editing & TherapyBoston, MA$63,252.80–$102,596 / yearThe ideal candidate will oversee cross-functional teams, manage collaborations with external partners (CROs, academic institutions, and biotech companies), and ensure timely and compliant execution of preclinical projects that support early therapeutic development. The 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.
Assistant Clinical Director Ellie Mental HealthAssistant Clinical DirectorAndover, Massachusetts$80,000–$90,000 / yearAs an Assistant Clinical Director at Ellie Mental Health, you'll share our vision for improving and expanding access to quality mental health care and thrive in an environment driven by our core values of authenticity, humor, compassion, creativity, acceptance, and determination. This role supports the Clinic Director and clinic staff, assists with staffing needs, provides resource support, and performs administrative oversight.
NewAssistant Clinical Director - CCS Eliot Community Human ServicesAssistant Clinical Director - CCSDanvers, MA$80,000–$90,000 / yearWe foster belonging in the workplace by identifying and removing barriers that may prevent individuals of all backgrounds from reaching their full potential, advancing into leadership roles, and fully engaging at all levels of the organization. Develop and implement systems to ensure warm handoffs between staff providing short term stabilization, staff providing urgent care services and CBHC Teams.
Feasibility Informatics Manager ICON PlcFeasibility Informatics ManagerCambridge, MARelevant parties include, but are not limited to: Proposal team members, Project Managers/Strategy Leads, Patient Recruitment & Retention Specialists, Site Identification Managers/Leads, Therapeutic Experts, Therapeutically Aligned clinical teams (as assigned), Business Development Associates, Sponsors, Quality Assurance Associates, and other internal/external experts. Role Summary: To serve as a technical feasibility strategy expert, leading and managing the process of clinical project feasibility in support of proposal teams by assisting Business Development with the generation of cost proposals, providing input and advice relating to operational strategy, and supporting client interactions and long-term strategic partnerships.
Manager, Patient Retention Kailera TherapeuticsManager, Patient RetentionWaltham, Massachusetts$127,000–$155,000 / yearDesign and distribute high-value site tools, patient counseling cheat sheets, and educational resources regarding the non-linear nature of GLP-1 weight loss journeys. Coordinate joint Kailera/CRO site outreach alongside IQVIA operational leads to provide direct, targeted support to struggling or high-risk clinical sites.
Director, Clinical Operations Oruka Therapeutics IncDirector, Clinical OperationsWaltham, MA$213,000–$240,000 / yearSignificant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities. Role Overview: We are seeking an exceptionally nimble and flexible Director of Clinical Operations who has a track record of achievement across all aspects of trial setup and execution in a fast paced small biotech with limited infrastructure and resources.
Enterprise Digital Systems Clinical Lead - Ambulatory Pathology (Beaker Ap/Cp) Brigham and Women's HospitalEnterprise Digital Systems Clinical Lead - Ambulatory Pathology (Beaker Ap/Cp)Somerville, MAThe Enterprise Digital System Clinical Lead- Ambulatory Pathology provides clinical informatics leadership for Epic systems supporting laboratory (Beaker- AP/CP) and non-laboratory clinical workflows related to pathology across ambulatory settings. The role includes ownership of highly variable and cross-setting workflows, including ambulatory and specialty diagnostic pathways, requiring coordination across clinical care teams, laboratory operations, and external partners.