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The role also involves coaching VO team members to resolve issues from a QC standpoint and serving as a primary reviewer of QC data for inspection readiness. Thus, the candidate should also have an understanding of various clinical trial activities such as Clinical Trial Management Services, clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.
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Working within a team environment and leading functional internal audits of VO's electronical Trial Master File (eTMF) and Contract Repositories to ensure meticulous oversight of VO's documentations, adherence to work procedures, compliance standards, and the preservation of data integrity.
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Daily activities will include, but are not limited to, working within a team environment and leading functional internal audits of VO's electronical Trial Master File (eTMF) and Contract Repositories to ensure meticulous oversight of VO's documentations, adherence to work procedures, compliance standards, and the preservation of data integrity.
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Demonstrates a thorough knowledge of Good Clinical Practice GCP, Good Pharmacovigilance Practices GVP, Good Laboratory Practice GLP, Good Documentation Practice GDP and ICH E6 R2 compliance requirements.
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Job Description :Nurse Reviewer ILocation: Within 50 miles of a pulse point in the following states:CaliforniaColoradoNevadaTennesseeShift: Four 10 hour shifts from 8 am - 6 pm CST The Nurse Reviewer I is responsible for conducting preauthorization, out of network and appropriateness of treatment reviews for diagnostic imaging services by utilizing appropriate policies, clinical and department guidelines.
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Serve as the IT compliance reviewer for new system validations. Assist in IT Vendor Management. Serve as the IT compliance reviewer for new system validations. Maintain IT compliance calendar (quarterly SOX reviews and GxP changes, for example.
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Serving as an expert liaison between the research investigator and the reviewer; educate parties on relevant and emerging regulations and related risk management issues. Demonstrated understanding of the principles of human/animal research protection standards.
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Trial Master File (TMF) Seeking a Vendor Outsourcing, QC Specialist who will report to the Senior Manager of Vendor Outsourcing (VO). Candidate has 3+ years of relevant experience in the pharmaceutical or biopharmaceutical industry; and, has a BS or BA.
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Responsiblefor obtaining initial insurance authorizations for all applicable coverage andfor appropriate level of clinical care.
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TA Specialist is the medical reviewer of promotional (e.g., PRC) and medical materials (e.g., MRC). TA specialist collaborates with affiliate MI and relevant internal partners who may include medical affairs, development, regulatory, global patient safety and operations, and commercial, to manage global response topics and content.
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We have immediate openings a Tax Reviewer / Tax Manager in our firm. Title: Tax Manager / Reviewer. Tax Reviewer / Manager. We have immediate openings a Tax Reviewer / Tax Manager in our firm.
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The UM Nurse will work closely with the UM/QI Manager, MSO UM team, MSO Medical Director, and MSO Physician Reviewer on UM case reviews. Provides cross coverage for MSO Nurse Case Managers and performs transition of care services, including post-discharge follow-up, medication reconciliation, home visit, and screening members for complex case management criteria.
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Candidate has 5+ years of relevant experience in the pharmaceutical or biopharmaceutical industry; and, has a BS or BA.(1) PMP certification or equivalent certification, (2) Candidates can be current or former project managers & (3) Project management experience in Pharmaceutical or Healthcare industries.
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Supporting mailbox- analytical operations will send documents into mailbox and the person will need to assign the document to reviewer. Reviewing to know the requirements for those types of validations and protocols and understand the compliance – will review and send on to next reviewer analytical partner – they are ensuring compliance and must have analytical knowledge to understand if in compliance or not.
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LeetCode is seeking an expert problem solver with strong English writing skills to join our team as a Content Problem Reviewer. Ability to work effectively in a remote, part-time, and contract-based role.
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reviewer job in San Carlos, CA
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