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. 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.
NewClinical Research Coordinator I Brigham and Women's HospitalClinical Research Coordinator IBoston, MA$20.16–$29.01 / hourHe/she/they will be responsible for patient scheduling and recruitment as well as all subject-oriented study procedures, such as administration of psychiatric scales, careful monitoring of adverse events, administrative duties related to the careful operation of study protocol, and database management and quality assurance. Our mission is to: (1) foster collaborative partnerships across sectors; (2) build school capacity to support student behavioral health; (3) uplift innovative, research informed prevention and intervention models; and (4) translate research into sustainable, scalable practice and policy.
Clinical Project Manager III Integrated Resources, IncClinical Project Manager IIILexington, MassachusettsFull timeResponsibilities % of Time Job Function and Description 10 %: • Represents and leads the study team to design, develop and deliver the clinical study in accordance with the clinical development plan/strategy, budget and timeline • Authors/contributes to clinical study documents. Title: Clinical Project Manager III Location: Lexington, MA, United States Duration: 06+ Months Job Details: • Responsible for the planning, implementation, execution and management of one or more complex clinical research studies.
NewDirector, Clinical Research, Obesity Merck & Co IncDirector, Clinical Research, ObesityBoston, MA$255,800–$402,700 / yearWork closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the team in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs, and of internal and external expert opinion on scientific questions relevant to his/her areas of responsibility. The Director (Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the Metabolism section of the Atherosclerosis & Metabolism therapeutic area, with a focus on obesity and obesity-related disorders.
Clinical Trial Manager BiogenClinical Trial ManagerCambridge, MassachusettsWorking closely with cross-functional partners, study sites, and external vendors, you will manage the day-to-day operations of clinical trials, tracking progress and identifying risks. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
Director/Sr. Director, Clinical Operations - Oncology Programs Frontier MedicinesDirector/Sr. Director, Clinical Operations - Oncology ProgramsBoston, MA$185,000–$250,000 / yearFrontier Medicines is seeking two experienced Clinical Operations leaders, at the Director or Senior Director level, to drive the operational strategy and execution of our oncology programs as they advance through clinical development. The ideal candidate brings deep oncology experience, strong global study oversight, and the ability to influence stakeholders, anticipate challenges, and deliver results in a dynamic biotech environment.
Clinical Trial Manager Seaport TherapeuticsClinical Trial ManagerBoston, Massachusetts$133,000–$150,000 / yearThe ideal candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a “we own it” mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects.
Clinical Research Associate Integrated Resources, IncClinical Research AssociateLexington, MassachusettsFull timeThe in-house Clinical Research Associate (CRA) is responsible for providing support for day to day clinical study activities under general supervision of the Clinical Project Manager(s). Assists study team with preparation for audits/inspections Reviews clinical close out monitoring visit reports for oversight and escalates issues to the Clinical Project Manager.
NewClinical Research Coordinator I Mass General BrighamClinical Research Coordinator IBoston, MassachusettsHe/she/they will be responsible for patient scheduling and recruitment as well as all subject-oriented study procedures, such as administration of psychiatric scales, careful monitoring of adverse events, administrative duties related to the careful operation of study protocol, and database management and quality assurance. Our mission is to: (1) foster collaborative partnerships across sectors; (2) build school capacity to support student behavioral health; (3) uplift innovative, research informed prevention and intervention models; and (4) translate research into sustainable, scalable practice and policy.
NewSr. Manager, Clinical Supplies Project Manager ModernaTXSr. Manager, Clinical Supplies Project ManagerCambridge, MassachusettsWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Manages/Works with third party vendors, Functional Leads and interface with CMC for Production Planning & Distribution; develops forecast of all drug supply needs and works with CMC department to ensure goals are met.
Clinical Scientist, Ophthalmology SanofiClinical Scientist, OphthalmologyCambridge, MA$148,500–$214,500 / yearThe primary purpose of the Clinical Scientist's position is to assist/support the Clinical Research Director in the medical/scientific contribution for ophthalmology clinical studies, including: supporting operational activities pertaining to protocol development (such as Informed Consent and committee charters), validation and clinical case review of study data, review of study plans and draft study reports/publications for accuracy, literature review and analysis, and preparation of responses for investigators, study teams, ethics committees, or regulatory authorities. Contribute to preparation and/or review of documents related to studies requiring scientific background (submission portfolio, abbreviated protocol/protocol/amended protocol, patient written information, presentations/communications to internal or external partners, study plans, study reports, trial disclosure form).
Senior Clinical Trial Manager GaldermaSenior Clinical Trial ManagerBoston, Massachusetts$110,000–$135,000 / yearWhere pay falls withing the range may vary based on many factors, including, but not limited to, job responsibilities, skills, experience, education, certifications, location and applicable geographic pay zones, market conditions, internal equity and business considerations. Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else.
Senior Clinical Operation Lead Integrated Resources, IncSenior Clinical Operation LeadCambridge, MassachusettsContractorKNOWLEDGE, SKILLS & ABILITIES: • At 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. Has a robust understanding of the study design including rationale, end points and patient population, and will ensure that the operational strategy supports both feasibility and scientific integrity.
Clinical Contracts Manager, Cambridge, MA Isomorphic LabsClinical Contracts Manager, Cambridge, MACambridge, MAOperating at an organizational level, this role drives vendor selection, supports negotiation of Master Service Agreements (MSAs) and Clinical Trial Agreements (CTAs), and manages vendor related study budgets and contract lifecycle activities. By harnessing AI’s powerful capabilities, we can use it to model complex biological phenomena to help design novel molecules, anticipate how drugs will perform and develop innovative medicines to treat and cure some of the world’s most devastating diseases.
Senior Manager, Clinical Data Management MBX BiosciencesSenior Manager, Clinical Data ManagementBurlington, MAOur pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism, currently preparing for Phase 3 development, and a growing obesity portfolio that includes MBX 4291 in Phase 1 development, MBX 5765, a next-generation amycretin prodrug designed for once-monthly-dosing, as well as MBX 6180, a GLP/GIP/GCGR triple agonist prodrug for once monthly dosing; all of which optimize our PEP platform. This role will provide hands-on leadership on day-to-day data management activities across MBX portfolio to ensure high quality and inspection ready clinical databases and data from all sources, while serving as a key data management partner to Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Safety, Quality, Medical Writing, and external data vendors.
Sr. Clinical Study Manager Integrated Resources, IncSr. 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. In collaboration with Study Execution Team (functions, Strategic Partners, and vendors), identify risks to study and suggest risk mitigation plans, with oversight of Clinical Program Manager and Associate Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning.
Clinical Research Assistant II Beth Israel Lahey HealthClinical Research Assistant IIBoston, MassachusettsCustomer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Extracts data on protocol subjects from hospital records, outpatient charts and private physician office records in order to complete case report forms required by specific protocols.
Manager Clinical Data Monte Rosa Therapeutics, IncManager Clinical DataBoston, MassachusettsFull timeThis individual will work closely with Clinical Operations, Biostats and Programming, Medical, Safety, Regulatory, external CROs, and technology vendors to ensure high-quality, inspection-ready clinical data. Manage CROs, EDC vendors, central labs, imaging vendors, eCOA providers, IRT vendors, and other data providers.
Contracts Assistant Clinical Vendor Management Integrated Resources, IncContracts Assistant Clinical Vendor ManagementCambridge, MassachusettsContractorMust have excellent communication skills, the ability to work efficiently and to perform tasks simultaneously with minimum supervision in a fast paced environment, exceptional organizational skills with a demonstrated ability to work in an accurate manner, great attention to detail, the ability to exercise sound judgment and determine priorities, the ability to work as part of a dynamic team, the ability to execute activities under tight timelines and high stress situations, proficiency with computers including MS Office suite with emphasis on Excel and Word, and the ability to quickly learn new technologies and processes. The Contracts Assistant will liaise with both internal and external stakeholders as required in the execution and document management of clinical contracts, management of purchase order (PO) requisitions, in addition to general administrative activities including the review, migration and cleanup of contractual data.
NewClinical Research Coordinator Boston Children's HospitalClinical Research CoordinatorBoston, MAThis position will provide support across several different research projects, including a study about stigma and health of bisexual adolescents/young adults and a study expanding an online intervention for families with transgender and nonbinary adolescents. Key Responsibilities: Project management for GenderWise Lab studies (e.g., tracking and reporting progress and expenses, managing IRB protocols, maintaining staff procedure guides).