Clinical Operations Leader Gates FoundationClinical Operations LeaderCambridge, MassachusettsThe COL will be responsible for ensuring that operational plans are developed to execute clinical studies and deliver quality data through all clinical trial phases across all programs in their assigned portfolio in accordance with the protocol, in compliance with ethical and regulatory requirements and in accordance with company SOPs, GCP and ICH guidelines within timelines and on budget. The successful candidate will be an innovative and collaborative individual who thrives in a “get it done” type of environment with diverse clinical operations experience and the following mix of personal and professional characteristics: 15+ years experience of Clinical Operations experience at biotechnology or pharmaceutical company or CRO, with at least 5+ years of people management.
NewClinical Research & Development Associate Director AstraZeneca PlcClinical Research & Development Associate DirectorWaltham, MAPhD, or equivalent) in a scientific, medical, or health-related discipline; Comprehensive knowledge of the drug development process; Demonstrated knowledge of AstraZeneca line and project management tools and processes; Good understanding of the therapeutic areas related to AZ products; Ability to understand integrated worldwide and regional delivery needs; Very good knowledge of oral and written communication in English; Ability to travel nationally and internationally. Internal: Study Delivery personnel; Data Management Centre representatives; Clinical Project Team and therapy area personnel; Clinical Development personnel; Clinical Pharmacology Units; Study Site personnel; Regional Monitoring personnel; Other Skill Centres as appropriate.
Child & Adolescent Psychiatrist Hybrid, MA Boston Neurobehavioral AssociatesChild & Adolescent Psychiatrist Hybrid, MAWaltham, MALed by Mohammad Munir, MD, the team of psychiatrists, nurse practitioners, physician assistants, psychologists, therapists, neuropsychologists, and other medical professionals collaborate to provide well-rounded care individualized for each patient. The practice regularly cares for patients who are dealing with depression, bipolar, anxiety, insomnia, attention-deficit hyperactivity disorder (ADHD), and OCD, among other conditions.
Program Manager Integrated Resources, IncProgram ManagerMansfield, MassachusettsContractorPosition Summary: · The PMV Data Manager is responsible for leading a group of PMV Data Analysts in developing statistically based ad hoc reports utilizing data generated by the Client complaint system to assist in the evaluation of safety triggers by PMV Analysts, providing leadership in the administration of the Client Complaint Tracking System (CTS) across the various Surgical Solutions Group sites, developing systems to provide support and tracking of ad hoc reporting outside the complaint group, as well as development and maintenance of the PMV SharePoint site. Location: Mansfield, MA Duration: 12+Months (Possibility of extension) Job Role: · This position is probably most closely associated with a Quality Systems Manager (IT oriented), with good program management skills.
Project Coordinator Integrated Resources, IncProject CoordinatorCambridge, MassachusettsFull timeThe Project Coordinator creates various contractual documents such as confidential disclosure agreements, master service agreements, master consulting agreements, and fair market value assessments. The Project Coordinator is responsible for supporting Project Managers on various projects such as but not limited, filing, product launches and regulatory commitments as needed.
Sr. IT Project Manager Integrated Resources, IncSr. IT Project ManagerCambridge, MassachusettsContractorA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. Ensures that assigned projects are conducted in compliance with applicable regulatory, information technology, enterprise, and departmental regulations, guidance, policies, procedures and methodologies.
Sr Lead QA Analyst Integrated Resources, IncSr Lead QA AnalystCambridge, MassachusettsContractorPrincipal duties and responsibilities: Approve system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities. Job impact: The Quality Assurance and Validation Specialist's role is essential in maintaining systems that are compliant with both regulatory (e.g., FDA) and corporate requirements and good business practices.
NewAssociate Principal Scientist, Clinical Research Merck & Co IncAssociate Principal Scientist, Clinical ResearchBoston, MA$142,400–$224,100 / yearTranslational Medicine (TMed) drives early clinical development of novel therapeutics by partnering with Discovery Sciences and Late-Stage Clinical Research to translate scientific discoveries into human proof-of-concept and advance the most promising candidates through the pipeline to patients. Leads and directs teams through key study planning, development, and execution activities, including program overviews, issue escalation and mitigation, senior management presentations, cross-functional governance meetings, and advisory meeting preparation.
Director, Healthcare Product Partnerships WhoopDirector, Healthcare Product PartnershipsBoston, Massachusetts$210,000–$250,000 / yearThis role will manage relationships with academic medical centers, research institutions, medical device and diagnostics companies, and digital health platforms, with the goal of expanding WHOOP's physiological signal set, generating clinical evidence, and deepening product integration across the healthcare ecosystem. This role will work closely with leaders across Product, Data Science, Clinical & Medical Operations, Regulatory, and Legal to bring product and research partnerships from concept through execution, validation, and ongoing relationship management.
Clinical Research Manager Tufts UniversityClinical Research ManagerBoston, MassachusettsReporting to study leadership, this role provides study-wide project management and serves as the primary regulatory lead for the Tufts single IRB, coordinating across clinical operations, data management, laboratory operations, investigative project teams, documentation, training, and stakeholder communications. Serve as primary regulatory lead for the Tufts single IRB of record: prepare and maintain submissions, modifications, continuing reviews, reportable new information, consent revisions, reliance agreements, and the study regulatory binder; advise investigators and site staff on compliance strategy across sites.
Java Developer Integrated Resources, IncJava DeveloperWeston, MassachusettsContractorA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Senior Medical Director, Clinical Development, Hematology, Nephrology, & Transplant, Cell Therapy AlexionSenior Medical Director, Clinical Development, Hematology, Nephrology, & Transplant, Cell TherapyBoston, MassachusettsResponsible for overseeing the clinical development strategy development and execution for 1 program, leading the clinical subteam to the GPT and represents clinical development on the GPT, contributing to the development of regulatory strategy, and representing the clinical program at regulatory meetings. This is what you will do: The Senior Medical Director, Clinical Development may lead the clinical sub-team or support the clinical sub-team and the global program team to build global clinical development plans and contributes to the development of asset level and therapeutic area strategies.
NewSenior Product Lead, Clinical Insights CVS Health CorpSenior Product Lead, Clinical InsightsBoston, MA$106,605–$260,590 / yearProduct Lead, Clinical Insights supporting Screening & Diagnosis, Quality Measurement, or Care Management use cases across multiple CVS Health businesses, you will serve as the strategic bridge between the CIE's platform and the business' operational priorities. Performance & Impact Monitoring: Define and monitor key performance indicators (KPIs) to measure the success of the Clinical Insights Engine (e.g., provider acceptance rates, diagnostic accuracy, quality gap closure, intervention timeliness, etc.).
Quality Engineer Integrated Resources, IncQuality EngineerMansfield, MassachusettsContractorPrimary responsibilities for this position include risk assessment, maintenance, and management as documented within the risk management files, providing post market quality support and guidance through nonconformity assessment, supporting health hazard assessments, and contributing to the various aspects of CAPA such as containment determination, root cause investigation, and corrective action planning by utilizing their subject matter expertise across the organization. ESSENTIAL FUNCTIONS: · Support, Collaborate and drive post market quality activities with cross functional partners (R&D, manufacturing, post market vigilance, CAPA, change development, Supplier Quality, etc.) to ensure the proper application, use and updates of risk management files following product launch.
Change Management & Communications Lead Job Opportunity Integrated Resources, IncChange Management & Communications Lead Job OpportunityCambridge, MassachusettsContractorRMO Communication Deliverables: • "Walking Deck" – created for key stakeholders to be used as an elevator pitch to cascade information to impacted teams. • Coordinate activities with dependent projects, including Product Lifecycle Management (PLM) and End to End Artwork (ARTi) which are led by Company's Manufacturing (PO&T) organization.
TMF Doc Coordinator Integrated Resources, IncTMF Doc CoordinatorCambridge, MassachusettsContractorIncludes identification of missing documentation and follow-up with authors or other stakeholders to obtain missing items; performing quality reviews of files and any needed remediation (e.g., follow-up with sources, generating notes to file to explain any discrepancies); and completing file review documentation. Responsible for ensuring timely filing of TMF documentation; addressing backlog of unfilled documentation; performing periodic review and remediation of TMF.
Recruiter Integrated Resources, IncRecruiterLexington, MassachusettsContractorA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Contract and Agreement Specialist Integrated Resources, IncContract and Agreement SpecialistCambridge, MassachusettsContractorContract management; responsible for initiating contract renewals with MW functional service providers and partners, including negotiations/follow-up with vendors, ensuring appropriate signatures are obtained, ensuring purchase orders are in place, and filing final, fully executed contracts in Selectica. A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
Cell banking operator Integrated Resources, IncCell banking operatorAndover, MassachusettsContractorQUALIFICATIONS AND SKILLS NEEDED: • High school diploma or GED required with 1-2 years of relevant experience, Certificate in Biotechnology or Associates degree in a related field is preferred. Our Client is looking for Cell banking Operator or bench Scientist with good GMP, cell banking, shipping, SOP, experience…!
statistical programmer(SAS Programmer) Integrated Resources, Incstatistical programmer(SAS Programmer)Cambridge, MassachusettsContractorRoles and Responsibilities: The Biometrics Quality Team provides leadership and support for the Global Biometrics department, which consists of Data Management, Biostatistics and Statistical Programming. Strong project management skills; high attention to detail with proven ability to manage multiple, competing priorities; Ability to work effectively across functions and levels.