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Experience with Clinical Trial related systems, e.g. Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF, preferably Veeva Vault), Electronic Data Capture (EDC, preferably Medidata RAVE) and Large Scale Data Analytics (such as SpotFire, CluePoints, JReview or similar.
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Ensure the ongoing completeness of the electronic Trial Master File (eTMF) The Clinical Trial Manager (CTM) is accountable for delivery of selected and/or regional deliverables within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions to set up activities [e.g., Calyx, IRT, eRT], support site activation and recruitment, support data review/cleaning activities, support PI/ICF development.
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In MDM we collaborate with many departments of the business, and you’ll become familiar with dsm-firmenich MDM processes (+60 processes) of Material Introductions, Maintenance, Commercial, Packaging, Customer and Vendor master.
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Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, med ed) Subspecialty training in relevant therapeutic area preferred (Sickle Cell/Hemoglobinopathies) We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
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Position Summary / ObjectiveThe Senior Manager, GRS-CMC is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating / leading HA meetings); &/or post-approval submissions.
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Therapist (Part Time, Benefits Eligible)Total Comp Package: 30 hours per week w/ benefit eligible (medical, dental, PTO)Minimum 15 clinical hours delivered/week Our peak demand occurs from 3:30 pm to 8:30 est on Weekday hours and Daytime on the weekends.
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With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East. SpecialtiesProcess Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV and Staffing Services.
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The Clinical Nurse 2 or Clinical Nurse-NCL demonstrates within the competency domains of Continuous Quality Improvement, Evidence Based Practice and Research, Leadership, Person and Family Centered Care, Professionalism, Safety, Technology/Informatics, and Teamwork.
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Licensed Clinical Social Worker (LCSW)/ Licensed Marriage and Family Therapist (LMFT) / Licensed Professional Counselor (LPC). We are actively looking to hire talented Licensed Therapists in the Princeton Junction, Brick, Eatontown, Piscataway, North Brunswick, Mt Laurel, Lyndhurst and Cherry Hill, NJ area who are passionate about patient care and committed to clinical excellence.
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Actively looking for a Senior Scientist, Cell Therapy Process Development contributing to the development of early and late stage clinical cell therapy manufacturing processes. The ideal candidate for this position should have work experience in cell therapy process development, manufacturing science, analytical development, and familiarity with GMP/FDA/ICH guidelines.
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The Director of Trial Court Services must have the ability to effectuate Judiciary policymaking needs related to case flow processing. The Director of Trial Court Services must have the ability to effectuate Judiciary policymaking needs related to case flow processing.
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As an individual contributor operating within a matrix organization would facilitate the design, develop, optimize genomics and genetics biomarker assays and develop and execute the qualification/validation of these assays for clinical trial assays in house and/or potentially with external vendors.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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Career Paths: Fast-track your journey to becoming a Board Certified Behavior Analyst (BCBA) or Clinical Leader. Career Paths: Fast-track your journey to becoming a Board Certified Behavior Analyst (BCBA) or Clinical Leader.
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Demonstrated clinical trial experience in healthcare/medical/laboratory settings or equivalent. Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management, and regulatory issues.
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clinical trial master file jobs Title: trial master in Lawrence, NJ
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