Senior Clinical Document Management Specialist Integrated Resources, IncSenior Clinical Document Management SpecialistLexington, MassachusettsContractorPRIMARY DUTIES Reporting to the Clinical Documentation Team Lead, and working in collaboration with the clinical study teams, the Senior Clinical Document Management Specialist is responsible for the management and oversight of Trial Master File (TMF) records from set-up through to final archival of the clinical trial, ensuring compliance with company SOPs and processes, and all applicable regulations. Familiarity with various aspects of clinical trials and regulatory submissions, as well as strong knowledge of document management best practices.
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 Lead • Overseeing the tactical execution of the operational strategy by the partner CRO; effectively leads the study through oversight of the CRO • Driving performance, quality, timelines and relationships through the CRO partnership model • Chairs 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 issues. 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 group • Seeks interdependencies and synergies with other trials and programs to enhance superb planning and execution across all studies in a phase • Follows established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing model • Embodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the new CRO partnership model.
Project Manager, Clinical Lab Equipment Installation (Healthcare) DanaherProject Manager, Clinical Lab Equipment Installation (Healthcare)Boston, MARemote$80,000–$100,000 / yearThe Project Manager, Clinical Lab Equipment Installation is responsible for managing the implementation and installation of our diagnostic instrumentation portfolio in partnership with laboratory customers, hospital facilities teams, IT stakeholders, and other customer partners, while coordinating closely with internal Beckman Coulter teams to ensure successful project execution. The essential requirements of the job include: Bachelor's Degree with preference for 2+ years of experience with proven track record in managing projects, and be able to provide examples and project artifacts, i.e. Communication Plans, Project Plans, Risk Plans, etc.
Sr.Clinical Operations Lead Integrated Resources, IncSr.Clinical Operations LeadCambridge, MassachusettsFull timeWorks closely with key scientific leaders, CRO global lead, Vendor Management, Operation Lead, study or program MDs, Program Directors, Study Management Team members including Regulatory Affairs, Medical Affairs, Commercial, Discovery, and Analytical Development. Chairs 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 issues.
Manager, Clinical Study Lead Regeneron PharmaceuticalsManager, Clinical Study LeadUxbridge, MAAssigns tasks to Clinical Study Management staff and supports their deliverables; directly supervises CTM staff (work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight); recommends and participates in cross-functional and departmental process improvements; and identifies innovative, globally informed approaches to study execution and continuous improvement of CTM SOPs. Discover your role: Leads the cross-functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight, and oversees execution against planned timelines, deliverables, and budget while raising issues (conduct, quality, timelines, budget) to the Program Operations Lead and stakeholders and implementing corrective action.
Clinical Data and Analytics Lead Integrated Resources, IncClinical Data and Analytics LeadCambridge, MassachusettsFull time5+ years relevant work experience with a focus on data management • Deep understanding of drug development and biopharmaceutical industry required • Strong project management skills, and ability to effectively lead and collaborate with various business functions • High attention to detail including proven ability to manage multiple competing priorities • Experience overseeing outsourced clinical trials work performed by vendors • Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at vendor • Deep knowledge of clinical data management with full-service global CROs and FSPs • Demonstrated ability to influence without authority • Excellent written and oral communication skill. Liaises directly with internal customers (Medical functions, Statistical Programming, Clinical Operations, Biostatistics, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel).
Clinical Supply Chain Operations Manager RD PartnersClinical Supply Chain Operations ManagerCambridge, Massachusetts£141,440–£176,800Responsible for end-to-end execution of clinical supply activities including IRT, packaging, labeling, distribution, inventory management, returns, destruction, and study closeout. R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe.
Clinical Data Management Project Manager Integrated Resources, IncClinical Data Management Project ManagerCambridge, MassachusettsContractorMinimum of 5 years in the Data Management field, previous work with CROs and Data Management vendors is required, working in a global/cross-cultural setting is preferred In-depth knowledge and understanding of the drug development process and data management process. Technical/Software Skills: Familiarity with Oracle Clinical or other clinical data management system software; General software skills: Lotus Notes, MS Access, MS Word, MS Excel, MS Project Strong understanding of database programming concepts.
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.
Senior Clinical Trial Manager Treeline Biosciences, Inc.Senior Clinical Trial ManagerWatertown, MA$153,000–$197,600 / yearJob responsibilities include, but are not limited to, preparation of study related materials, enrollment tracking and reporting, relationship management with study sites and vendors (in particular CROs), supervision of study-related activities, identification of project risks and contingency planning. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes.
Clinical Safety Data Manager Integrated Resources, IncClinical Safety Data ManagerCambridge, MassachusettsFull timeThe AE Intake Clinical Trials Associate will provide partner / vendor oversight in relation to Clinical Trial safety report collection and will collaborate with other functions (e.g., Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others) to ensure consistency with regulations and with departmental goals and objectives. 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 10%.
Clinical Trials Safety Data Manager Integrated Resources, IncClinical Trials Safety Data ManagerCambridge, MassachusettsContractorClinical Trials Associate will provide partner / vendor oversight in relation to Clinical Trial safety report collection and will collaborate with other functions (e.g., Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others) to ensure consistency with regulations and with departmental goals and objectives. 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.
Clinical Research Coordinator I/Ii/Iii Opportunities - Multiple Locations Nationwide Headlands ResearchClinical Research Coordinator I/Ii/Iii Opportunities - Multiple Locations NationwidePlymouth, MA$45,000–$100,000 / yearThis general interest posting is designed for experienced Clinical Research Coordinators (CRCs) who may not see a current opening that aligns with their location, but want to be considered for future opportunities across our growing network of clinical research sites nationwide. They play a hands-on role in advancing new therapies, supporting patients through clinical trials, and ensuring studies are conducted with the highest level of quality and care.
Clinical Data Manager Integrated Resources, IncClinical Data ManagerCambridge, MassachusettsContractorManage performance of vendors, in addition to, Data Managers and Senior Data Managers, for studies/programs run from the US, EU or Asia through the following: • Define program-level strategy for data management tasks and deliverables. • Directs the work of external vendors providing data capture technologies, data processing capabilities and data management programming capabilities to achieve quality, timely, cost-effective program/study deliverables.
Manager, Clinical Science Relay TherapeuticsManager, 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.
NewBilingual Spanish Clinical Research Coordinator Mass General BrighamBilingual Spanish Clinical Research CoordinatorBoston, Massachusetts$21–$29.01 / hourFollowing established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc. and maintaining and updating data generated by the study. Clinical Research Coordinator (CRC): The Disparities Research Unit at Massachusetts General Hospital is seeking CRCs for a study focused on addressing health and healthcare inequities in socially vulnerable communities.
NewRN Clinical Research - MGH Mass General BrighamRN Clinical Research - MGHBoston, MassachusettsSummary: Accountable for interpreting the plan of medical care, assessment of patients' clinical decision-making regarding nursing care, assuring nursing care is provided in a safe and competent manner, providing individualized nursing care, and evaluating nursing care for groups of patients. The nurse will work closely with pregnant participants and their newborns and receive direct mentorship from principal investigator Dr. Camille E. Powe and an interdisciplinary team with expertise in endocrinology, obstetrics, maternal-fetal medicine, epidemiology, biostatistics, and clinical trials.
Clinical Research Nurse - Breast Dana-Farber Cancer InstituteClinical Research Nurse - BreastChestnut Hill, MA$42.65–$105.81 / hourIn addition, the CRN utilizes evidence-based nursing practice and has expertise in developing and coordinating a plan of care designed to meet the physical, psychological, and social needs of those cancer patients and their families undergoing therapy in a clinical research trial. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
NewClinical Research Assistant Mass General BrighamClinical Research AssistantSomerville, Massachusetts$17.71–$24.28 / hourThe Center for Women's Mental Health is seeking a detail-oriented Clinical Research Assistant (Medical Record Review) to support the National Pregnancy Registry for Psychiatric Medications (NPRPM), a prospective observational research study that evaluates pregnancy and infant outcomes following prenatal exposure to psychiatric medications. 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.
NewBilingual Clinical Research Coordinator II Mass General BrighamBilingual Clinical Research Coordinator IIBoston, Massachusetts$24.28–$39.43 / hourSummaryFollowing established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc. In the year ahead, we look forward to implementing several clinical trials, including a study on the feasibility and impact of long-acting PrEP injections and navigation services for people who inject drugs, an ongoing observational study of individuals who have had COVID, investigations into potential new therapies for Long COVID.