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Expertise in Web Services (REST), API Design, ORM, Spring MVC, Service Oriented Architecture (SOA), Cloud Computing Platforms (e.g., AWS, Azure, GCP) Containerization Technologies (e.g., Docker, Kubernetes), knowledge of Adobe Marketing Cloud a strong plus.
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Responsibilities of the Senior GCP Auditor :Perform GxP audits related to clinical research (investigator site audits, TMF audits, CRF audits, database audits, For-cause audits, supplier audits, regulatory inspection, etc.
$150,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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WillowTree’s client roster spans industries and growth stages, including T-Mobile, Marriott, Allianz, Dexcom, PepsiCo, Brightline Trains, Synchrony Financial, Domino’s, and Dairy Queen. In January 2023, WillowTree was acquired by TELUS International (Symbol: TIXT), a leading provider of next-generation digital customer experience (CX) solutions for global and disruptive brands.
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Requirements: A minimum of five (5) years of experience working in an oncology clinical research setting Strong computer skills with proficiency with MS Office and other related systems applications Excellent written and oral communication skills Knowledge of Good Clinical Practices (GCP) a plus Project management experience is a plus.
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GCP (Big Table, GKE, matching Enginer) Experience with CSR, Chatbot, LLM, ML will be preferred. GCP (Big Table, GKE, matching Enginer) Domain: Health Insurance biggest preference, then Healthcare, then either Financial or Security coming from somewhere that is heavily regulated and super compliant.
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Ensuring adherence to Good Clinical Practice (GCP) guidelines, regulatory requirements, and company SOPs throughout the conduct of clinical trials, maintaining the highest standards of data integrity and patient safety.
$165,000Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Knowledge of GMP (Good Manufacturing Practice) and GCP (Good Clinical Practice). Our team is proficient in various areas, including Clinical Data Management, Regulatory Submissions, Biostatistics, Statistical Programming, Data Analytics, and PK/PD analysis.
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Primary Job Responsibilities:Develop and maintain GCP Quality Systems and SOPs. Provide expert guidance on GCP regulations and requirements. Primary Job Requirements:Preferred: Bachelors or higher in clinical/medical science, professional certifications a plusRequired: 6+ years of experience with Sponsors, CROs, or GCP consulting.
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Comprehensive knowledge of regulatory guidelines (e.g., FDA, EMA, ICH, GCP). Knowledge: Robust understanding of GCP and ICH guidelines. Requirements About You: Education: A Master's Degree, Ph. D., PharmD, or a B.A./B.S. with commensurate clinical research experience is required.
$245,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Responsibilities Accountable for project related efforts for the delivery of studies or programs that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
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Remote work is allowed, and the frequency is at the discretion of management. Provide clinical leadership to CROs, other vendors, CRA team, and CTAs. Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines.
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The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. Interact with clinical research investigators, Key Opinion Leaders and sites.
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Supports external vendor selection and management process and assists in the development of RFP’s and vendor oversight plans. Their office-based employees follow a hybrid in-office schedule (Must be in the Waltham office 2-3 days per week.
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Plan, negotiate, and manage site budgets as well as facilitate site contracting process. Disseminate clinical program communications to all functional groups and leads program, study and team meetings.
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Collaborate with the integrator to implement CyberArk SCA to secure privileged access to cloud environments (AWS, Azure, GCP) Relevant certifications (e.g., CyberArk Defender, CyberArk Sentry, CISSP, CISM) are a plus.
$85 an hourExpandApply NowActive JobUpdated Today
gcp job Company: Ppd in Boston, MA
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