- Edwards Lifesciences (Boston, MA)
- …(AT) team. As the Clinical Research Monitor , you will ensure trial patients' safety by assuring trials are conducted ethically and within regulatory ... + Field monitoring of studies and data collection for clinical trials , assess all data documentation, reports,...within parameters of study hypothesis, as well as to monitor clinical trial /study safety, in… more
- Beth Israel Lahey Health (Boston, MA)
- …Regular **Scheduled Hours:** 40 **Work Shift:** Day (United States of America) The Clinical Trials Monitor (CTM) monitors and audits the ... research studies across all disease groups in the Cancer Clinical Trials Office. The CTM will also...SOPs, study protocols and supporting documents. (essential) + Reviews clinical trial and non-human primate data ensuring… more
- Actalent (Boston, MA)
- …to clinical research protocols, principles, and procedures * Ability to develop and monitor clinical trials budgets * Ability to engage in budget ... aspects related to the Center in collaboration with faculty directors * Responsible for clinical trial processes and provides support to the clinical … more
- ThermoFisher Scientific (Boston, MA)
- …a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of ... research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver... clinical research services provide end-to-end support for clinical trials from study start up to… more
- Actalent (Waltham, MA)
- …of study related documents (contracts, ICF(s), protocol(s), IB(s), etc.) + Prepare clinical study budgets, monitor budgets for variances and approve invoices, ... Manage contract research organizations (CRO) and other external vendors to support clinical studies and ensure compliance with quality systems + Independently manage… more
- Bristol Myers Squibb (Cambridge, MA)
- …and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials + Successfully leads, plans, and executes ... implementation all study startup/conduct/close-out activities as applicable + Evaluate innovative trial designs (collaboration with Medical Monitor / Clinical … more
- IQVIA (Boston, MA)
- …SOPs, policies and practices. **_Immediate need for candidates with CNS Clinical Trial Management experience._** **RESPONSIBILITIES** + Accountable for ensuring ... action plan and thereby ensure successful delivery to customer satisfaction. + Monitor clinical progress against contract and prepare/present project information… more
- Bristol Myers Squibb (Cambridge, MA)
- …access goals **Position Responsibilities** **Medical Monitoring** + Serves as an independent Medical Monitor for clinical trials from Phase 1 through ... early clinical assets from first-in-human through proof-of-concept and will prepare the clinical development plan, design clinical trials and lead the … more
- Bristol Myers Squibb (Cambridge, MA)
- …external networks **Position Responsibilities** **Medical Monitoring** + Serves as an independent Medical Monitor for clinical trials from Phase 1 through ... assets from first-in-human through proof-of-concept and will prepare the clinical development plan, design clinical trials... development strategy + Analyzing, interpreting, and acting on clinical trial data to support development +… more
- IQVIA (Boston, MA)
- …conducting clinical trials ; we're revolutionizing them. Your role as a Clinical Trial Vendor Manager will be instrumental in ensuring that our ... **Elevate Your Career as a Clinical Trial Vendor Manager!** **About the...to develop and refine training materials, ensuring site and monitor readiness through active participation and support. **What We're… more
- Actalent (Boston, MA)
- …+ Manages day-to-day operations and is responsible for administrative aspects + Responsible for clinical trial processes and provides support to the clinical ... and maintains partnerships with industry sponsors, other hospital collaborators and clinical trials network professionals as appropriate. + Is responsible… more
- Pfizer (Cambridge, MA)
- …rapidly changing business needs + Manage investigator record retention program across Pfizer clinical trials + Drive performance of CRO against TMF requirements, ... functions + Coordinate TMF Lock process & activities across clinical trial portfolio + Identify and resolve...issues and continuous improvement opportunities related to TMF + Monitor and manage the TMF performance and metrics +… more
- Sanofi Group (Cambridge, MA)
- …briefing packages for Regulatory agencies, extended synopsis/protocol for clinical trials , Investigator Brochure, Clinical Trial Authorization dossier ... lead for programs and responsible for leading successful clinical trials for novel therapeutics for Ophthalmologic...clinical operations teams + Implements strategies to identify, monitor and resolve clinical program/ trial … more
- Children's Hospital Boston (Boston, MA)
- …in clinical research. Experience as a research nurse, research coordinator or clinical trials monitor necessary + An understanding in the interpretation ... 75120BRJob Posting Title:IRB Education & Quality Improvement Program ManagerDepartment:Research- Clinical InvestigationsAutoReqId:75120BRStatus:Full-TimeStandard Hours per Week:40 Job Posting Category:ResearchJob… more
- Bristol Myers Squibb (Cambridge, MA)
- …as a medical monitor with proven track record designing and overseeing clinical trials , ideally both early and late stage + Experience supervising CRO-driven ... results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Position Responsibilities** +...demonstrated leadership in the design and execution of multiple clinical trials having had significant experience as… more
- J&J Family of Companies (Cambridge, MA)
- …+ Identifies and assesses medical risks and mitigation plans prior to and during clinical trials . + Follows Janssen SOPs for the SRP function including ... and/or Safety Management Team (SMT). + Reviews and interprets clinical trial data to enable timely internal...scientific advice meetings, DSURs). + Reports the status of clinical trials to management. **Qualifications** + Physician… more
- Children's Hospital Boston (Boston, MA)
- …and range from observational studies and registries to biobanking to interventional clinical trials of novel treatments. The Dana-Farber/Boston Children's Cancer ... be responsible for: + Oversight of their disease group's clinical trial portfolio and all related regulatory,...logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader… more
- Edwards Lifesciences (Boston, MA)
- …modify clinical databases, and tools and programs for data validation checks, and clinical trial reporting + Lead cross functional teams in the design and ... complex functional modules and provide data management expertise regarding clinical trials , protocols, and case report forms...and other database-related tasks during the life of a clinical trial to ensure data quality and… more
- Takeda Pharmaceuticals (Boston, MA)
- …the external investigator community. + Ensure successful planning, execution, and completion of clinical trials across all therapeutic areas and regions. + Drive ... operational excellence, efficiency, and quality in clinical trial management. + Foster a culture...and with cross-functional teams to ensure seamless execution of clinical trials . **ACCOUNTABILITIES:** + Lead and manage… more
- Beth Israel Lahey Health (Boston, MA)
- …of America) Under the general direction of the Associate Director of the Clinical Trials Office (CTO), the Senior Contracting Specialist works with ... investigators, clinical trial coordinators and industrial sponsors and...requirements. Works closely with the Associate Director of the Clinical Trials Office, BIDMC General Counsel, members… more