- 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
- Pfizer (Cambridge, MA)
- …monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for ... studies to meet the stated objectives. Assures that clinical trial objectives fit with the ...review and interpretation of efficacy and safety data from clinical trials ; this may include delivery of… 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
- Pfizer (Cambridge, MA)
- …but other specialists with experience in GI, Rheumatology, Allergy and Hematology clinical trials will be considered. Technical Skills: Experience in generating ... * Sit on project teams from FIH/POM/SOCA through POC trial completion to ensure that clinical development...of two in neurology. Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas… 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)
- …HOCT extended leadership team **Medical Monitoring:** + Oversees and/or serves as Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept ... development strategy + Analyzing, interpreting, and acting on Clinical Trial data towards development + Serving...unique perspectives in an inclusive culture, promoting diversity in clinical trials , while our shared values of… 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
- 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
- ThermoFisher Scientific (Waltham, 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
- 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 ... Scientists (CS) within the asset and/or indication + Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent;… 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
- Pfizer (Cambridge, MA)
- … Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all CDS activities including selection and application ... discovery sciences, ensuring drug safety and efficacy or supporting clinical trials , you will apply cutting edge...maintain key data management deliverables used to collect, review, monitor , and ensure the integrity of clinical … more
- IQVIA (Boston, MA)
- …operates. * Requires basic understanding of project finances.; * Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in ... Clinical Leads are an integral part of clinical trial delivery, working alongside clinical...including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …team, provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. CDCS leads the integration of collected ... (CDR). DCE contributes to the successful conduct of Takeda's clinical trials and to the delivery of...products. Further, CDCS efforts enable valid secondary use of clinical trial data throughout Takeda research groups… more
- Children's Hospital Boston (Boston, MA)
- …year of relevant work experience. + Minimum of one experience of conducting clinical trial experience + Analytical skills to resolve complex problems requiring ... II will coordinate activities of daily operations for Dr. Stephanie Sacharow's clinical research trials . Dr. Sacharow's research focuses on Phenylketonuria in… more
- Abbott (Burlington, MA)
- …conduct of clinical trials , including but not limited to: authoring clinical trial protocols, case report forms, informed consent forms, report of prior ... to author the scientific documents associated with design, conduct, and reporting of clinical trials in the therapeutic area of Heart Failure, particularly… more
- Pfizer (Cambridge, MA)
- …program through oversight of initial program activities, during implementationand monitoring of clinical trials , and during completion of final documents for ... procedural and scientific subject matter expertise to guide global trial leaders, clinical scientists and other ...Administer/Oversee global clinical research program(s): + Oversee clinical lead and clinician medical monitor activities… 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
- Edwards Lifesciences (Boston, MA)
- …biostatistician of assigned clinical trial (s) in US and international/global trial + Accountable for clinical trials assigned to direct reports ... Biostatistics, or related field with previous analytical experience in clinical trials with skill levels exceeding the...requirements of the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA… more