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Master of Science degree in Geology, Engineering or closely related field (i.e., environmental, biological, physical science) Arcadis is currently searching for an Entry-Level Geologist or Scientist or Environmental Engineer to join our Resilience Environment team in the Northeast.
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Oversee the development and maintenance of the Trial Master File (TMF), ensuring regular TMF audits and a final TMF that is complete and inspection-ready. We are also developing our own CAR-T cell therapy using T cells from the same healthy donor who could potentially provide HSCs for our shielded stem cell transplant and thereby, avoid issues of donor-mismatch.
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Identifies and supports the DSPV team with document management activities (e.g., electronic Trial Master File, Veeva), including maintaining electronic files internally, and collaborate cross- functionally with Client teams, CRO’s and vendors.
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Design and develop data capturing tools: Electronic Data Capture (EDC) Systems (Eg: iMedidata Rave and IBM Clinical) eCOA, IRT; Manage electronic Trial Master File (eTMF) QC review eg: Veeva Vault; Lead the Audit and Inspection/Submission Readiness activities like documentation of QC and preparing Storyboards (Eg: FDA/EMA Submissions.
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Experience evaluating and correcting data quality and completeness issues, drive consensus on attribute definitions, master data management and process re-engineering. We’re looking for an experienced Senior Principal Software Engineer and thought leader to join our growing team focused on rationalizing data management and analytics in OCI's hardware and data center space.
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In addition to the Master's in Global Business Administration (GBA), the Fletcher School also offers Master's in Law & Diplomacy (MALD), a Master's in Global Affairs (MGA), a Master's in International Law (LLM), a Master's in International Business (MIB), a Global Master of Arts (GMAP), and a PhD.
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Works with Study Start-up and coordinates study start-up activities including feasibility, investigational product and materials preparation, trial master file set- up, CRFs, regulatory documents, and site contracts in conjunction with other relevant departments.
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Master Technician: All eight Series A1 thru A8 f. We Guarantee The Lowest PriceSince 1926, the Quirk family and VIP have been the place where New Englanders turn for the tires and professional auto service they need to keep their vehicles running at peak performance.
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What You'll Need: 2+ years of professional experience in engineering mechanics, structural dynamics, and finite element analysis (FEA) with Master of Science or Master of Engineering in Structural Engineering - OR - 0+ years of professional experience in engineering mechanics, structural dynamics, and finite element analysis (FEA) with Doctorate in Structural Engineering Ability to obtain Professional Engineer (PE) or Structural Engineer (SE) registration within five years.
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Project Management Professional (PMP) or Program Management Professional (PgMP) required; Certified Scrum Master (CSM) certification preferred in addition. This will involve re-internalizing certain GCP deliverables and refreshing the clinical biologics bioanalytical outsourcing model for greater efficiencies within BR. The program will consist of four major workstreams to deliver the above outcomes.
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Manage and maintain master data, forms & templates, process documentation, key metrics, and contribute to policy/procedure development for different areas within CSD. Desire familiarity with business intelligence and data visualization tools like SAP BusinessObjects BI, SAP Analytics Cloud, Microsoft Power BI, and cloud-based procurement solutions like Jaggaer eProcurement and Ariba.
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Oversee the Trial Master File (TMF) and assist with periodic audit of the TMF. Oversee the Trial Master File (TMF) and assist with periodic audit of the TMF. Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science and QA team members, both internally and externally.
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Establish and maintain the Validation Master Plan (VMP) for manufacturing process, aseptic process, and shipping validation, working cross-functionally with key stake holders and responsible functions to ensure the defined VMP activities are executed and maintained and all supporting documentation is complete and accurate.
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Experience working in electronic Trial Master File specifically Veeva Vault eTMF platform preferred. Understanding of Trial Master File including understanding of DIA TMF Reference Model preferred.
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Owns the Trial Master File for assigned trials; ensures appropriate quality oversight and QC of required elements of TMF. Owns the Trial Master File for assigned trials; ensures appropriate quality oversight and QC of required elements of TMF.
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master job in Lexington, MA
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