Strategic Sourcing Manager AtriumStrategic Sourcing ManagerLexington, MA$45–$50 / hourThis position will partner with internal R&D stakeholders and external suppliers to execute sourcing initiatives, support supplier selection and negotiations, manage vendor relationships, and identify opportunities to improve cost, quality, and operational efficiency. The Strategic Sourcing Manager will support sourcing and procurement activities across the Research and Development organization, with a particular focus on clinical services and Contract Research Organization (CRO) sourcing.
NewClinical Research Manager III, Real-world Science Thermo Fisher Scientific IncClinical Research Manager III, Real-world ScienceWaltham, MA$105,000–$115,000 / yearWe provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Job Description: The Clinical Research Manager III independently leads complex, high-visibility clinical research projects, ensuring strong scientific quality, operational performance, financial oversight, and client satisfaction.
Clinical Research Coordinator Alcanza Clinical Research LLCClinical Research CoordinatorMAScheduling subjects for study visits and conducts appointment reminders; Building/updating source as needed; Conducting monitoring visits and resolves issues as needed in a timely manner; Ensuring study related reports and patient results are reviewed by investigator in a timely manner; Filing SAE/Deviation reports to Sponsor and IRB as needed; Documenting and reporting adverse events; Reporting non-compliance to appropriate staff in timely manner; Maintaining positive and effective communication with clients and team members; Always practicing ALCOAC principles with all documentation; May assist with study recruitment, patient enrollment, and tracking as needed; Maintaining confidentiality of patients, customers and company information, and; Performing all other duties as requested or assigned. Responsibilities may include but are not limited to: Screening of patients for study enrollment; Patient consents; Patient follow-up visits; Documenting in source clinic charts; Entering data in EDC and answers queries; Obtaining vital signs and ECGs; May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Requesting and tracking medical record requests; Updating and maintaining logs, chart filings; Maintaining & ordering study specific supplies;].
Clinical Research Registered Nurse ( PT WeekDay) Alcanza Clinical Research LLCClinical Research Registered Nurse ( PT WeekDay)Methuen, MARequesting and tracking medical record requests; Updating and maintaining logs, chart filings; Maintaining & ordering study specific supplies; Scheduling subjects for study visits and conducts appointment reminders; Building/updating source as needed; Conducting monitoring visits and resolves issues as needed in a timely manner; Ensuring study related reports and patient results are reviewed by investigator in a timely manner; o Filing SAE/Deviation reports to Sponsor and IRB as needed; o Documenting and reporting adverse events; o Reporting non-compliance to appropriate staff in timely manner; o Maintaining positive and effective communication with clients and team members; o Always practicing ALCOAC principles with all documentation; Be thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research study; Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc. Responsibilities may include but are not limited to: Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines: Screening of patients for study enrollment; Patient consents; Patient follow-up visits; Documenting in source clinic charts; Entering data in EDC and answers queries; Obtaining vital signs and ECGs; May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Performing procedures commensurate with licensure including vitals, ECGs/EKGs, venipunctures, injections, infusions, mixing drug and/or dispense investigational product; etc.
NewAssociate Director, Project Manager Country Operations Alexion Pharmaceuticals IncAssociate Director, Project Manager Country OperationsBoston, MA$142,171.20–$213,256.80 / yearThe AD Project Manager Country Operations (AD PMCO) is accountable within their countries for the successful execution of study deliverables and the quality execution of high priority and / or complex protocol procedures through adherence to good clinical practices (GCP), evolving regulatory requirements, ALXN/AZ working procedures with the agreed resources and ensuring quality and consistency in timely completion of site management and monitoring activities. The AD PMCO is accountable for leading local study teams, ensuring rapid start up activities across assigned studies, ensuring that sites are identified, feasibility is conducted, site qualifications performed, the study is submitted to the relevant authorities for evaluation, sites are set up, monitored, closed and final documentation archived.
Senior Manager, Regulatory Affairs, Operations Xenon PharmaceuticalsSenior Manager, Regulatory Affairs, OperationsNeedham, MassachusettsOur Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Clinical Research Registered Nurse ( PT WeekDay) Alcanza Clinical ResearchClinical Research Registered Nurse ( PT WeekDay)Methuen, MassachusettsRequesting and tracking medical record requests; Updating and maintaining logs, chart filings; Maintaining & ordering study specific supplies; Scheduling subjects for study visits and conducts appointment reminders; Building/updating source as needed; Conducting monitoring visits and resolves issues as needed in a timely manner; Ensuring study related reports and patient results are reviewed by investigator in a timely manner; o Filing SAE/Deviation reports to Sponsor and IRB as needed; o Documenting and reporting adverse events; o Reporting non-compliance to appropriate staff in timely manner; o Maintaining positive and effective communication with clients and team members; o Always practicing ALCOAC principles with all documentation; Be thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research study; Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc. Responsibilities may include but are not limited to: Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines: Screening of patients for study enrollment; Patient consents; Patient follow-up visits; Documenting in source clinic charts; Entering data in EDC and answers queries; Obtaining vital signs and ECGs; May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Performing procedures commensurate with licensure including vitals, ECGs/EKGs, venipunctures, injections, infusions, mixing drug and/or dispense investigational product; etc.
Clinical Research Associate Alira HealthClinical Research AssociateFramingham, MassachusettsCRAs work closely with the In-house CRAs, Lead CRAs, Director of Clinical Monitoring and Project Managers to ensure sites’ protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
Clinical Research Associate CRA Alira HealthClinical Research Associate CRABoston, MassachusettsThe CRA works closely with Lead CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. The CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality.
Lead Clinical Research Associate Alira HealthLead Clinical Research AssociateBoston, MassachusettsLead CRAs work closely with US: Director of Clinical Monitoring, In-house CRAs, field CRAs, EU: Associate Director of Clinical Monitoring, CRAs, CTCs and Clinical Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
Senior Manager, Clinical Scientist Vor BioSenior Manager, Clinical ScientistBoston, MA$160,000–$175,000 / yearContributes to preparation and/or review of any documents related to the studies and requiring a scientific background (abbreviated protocol/protocol/amended protocol, informed consent form, presentations/communication to internal or external partners, study plans including medical monitoring plan, safety management plan, risk mitigation plan and recruitment materials). Contributes to definition of the centralized monitoring strategy in consistency with the planned statistical analysis and is involved in study data validation and review processes, support the Head of PV for Clinical Case review (all safety events), notably to anticipate and prevent last minute queries or backlog and smoothen the process.
Director of Clinical Quality Integrated Resources, IncDirector of Clinical QualityCambridge, MassachusettsContractorPerson must be able to coordinate other QA contractors for auditsMust also be able to deliver SOP's and processes andThis is ONLY in the GCP area Must have GCP experience Must have Pharma Experience within Quality Assurance Coordinating audits (internal, external) Inspection experience (FDA) Need to have worked in a development program so they know how to coordinate audits for a development programJob Description:Job Title: Director, Vaccines Clinical Compound Support Quality Assurance OBJECTIVES: • Plays a leadership role in ensuring that investigator, vendor, facility and system audits are conducted, for communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are implemented. EXPERIENCE, KNOWLEDGE AND SKILLS: Knowledge and Skills: In-depth knowledge of the applicable GXP regulations, FDA Good Clinical Practices, ICH Guidelines, FDA Regulations and Guidances and Computer System Validation • Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
Senior Clinical Trial Manager Actalent IncSenior Clinical Trial ManagerWaltham, MA$88–$103 / hourThe Senior Clinical Trial Manager serves as the Clinical Operations lead on cross-functional teams, driving operational excellence across study start-up, site activation, monitoring, and enrollment for a global Phase III trial in the rare disease and neuromuscular space. Collaborate closely with cross-functional teams, including Clinical Operations, Development, vendors, investigators, and study sites, to resolve issues and maintain operational momentum.
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.
Global Patient Access Strategy Lead (Sr. Manager) Takeda Pharmaceutical Co LtdGlobal Patient Access Strategy Lead (Sr. Manager)Cambridge, MA$178,100–$244,860 / yearLocation: While a primary location is identified for this role, qualified internal candidates located in Zürich may also be considered, subject to business needs, role requirements, talent availability, and local legal requirements. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
Executive Director, Clinical Quality Assurance Wave Life Sciences LtdExecutive Director, Clinical Quality AssuranceLexington, MA$260,000–$350,000 / yearThis role partners closely with GMP Quality Assurance and Discovery and Development senior leaders and stakeholders to develop, implement, and continuously improve global and local GLP/GCP quality strategies that align with Wave program pipeline goals and objectives, setting the overall vision and long-term priorities for the Clinical Quality Assurance organization. Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington's disease, as well as several preclinical programs utilizing our versatile RNA medicines platform.
Director, Clinical Program Quality & Excellence (CPQE), Oncology Takeda Pharmaceutical Co LtdDirector, Clinical Program Quality & Excellence (CPQE), OncologyCambridge, MA$177,000–$278,080 / yearResponsible to lead global GCP inspection strategy for assigned asset-level clinical programs, leading the planning for submission‑related inspections, representing Takeda as a Subject Matter Expert (SME) in clinical program quality oversight during regulatory interactions. Responsible to support and mentor the CPQ team for assigned Study Execution Teams (SETs) in the development, implementation and refinement of a proactive quality oversight model, embedding real-time inspection readiness by driving proactive compliance, documentation quality and the framework for proactive investigation and cross‑functional resolution of quality events.
Clinical Trial Manager Frontier Medicines CorpClinical Trial ManagerBoston, MADirector, Clinical Operations, you will serve as a key operational contact for our CROs and trial sites, helping drive feasibility assessments, site selection, start-up, maintenance, and close-out. This is a hybrid role based in our Boston, MA office, with an expectation of 2-3 days per week onsite, plus periodic travel to trial sites and CRO/vendor meetings as needed.
Director, Clinical Program Quality Takeda Pharmaceutical Co LtdDirector, Clinical Program QualityBoston, MA$177,000–$278,080 / yearYou will serve as a trusted strategic advisor within key asset-level governance forums, including the Global Program Team, Clinical Sub-Team, and Clinical Review Board, providing objective guidance on emerging risks, critical quality issues, and mitigation strategies that protect program continuity and maximize asset value. About the role: As the Director, Clinical Program Quality, you will shape and lead a proactive, risk-based quality management strategy across clinical assets, driving exceptional clinical program performance, strengthening regulatory confidence, and accelerating time to market through the early identification and mitigation of systemic compliance risks.
Clinical Research Coordinator I - General Internal Medicine (Bilingual Or Spanish-Speaking Applicants Encouraged To Apply) Tufts MedicineClinical Research Coordinator I - General Internal Medicine (Bilingual Or Spanish-Speaking Applicants Encouraged To Apply)Boston, MA$44,778.55–$55,978.47 / yearAssists with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review such as amendments, adverse event reporting and annual reviews. May require the following proficiency: work is closely supervised, problems faced are not typically difficult or complex, and explains facts, policies and practices related to job area.