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Review and file study documentation in the Trial Master File (TMF) Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; review and file study documentation in the trial master file (TMF) system acceptable for audit.
Full-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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Strong understanding of the Trial Master File structure (TMF) Review study plans, including; Clinical Monitoring, Communication, Project Management, and electronic Trial Master File (eTMF) Management.
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Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF QC/audits. Minimum 2-4+ years of clinical trial management experience working for a Sponsor company, CRA/field monitor, or CRO setting.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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Review and reconcile site and Investigator binders and the Trial Master File (TMF). Perform User Acceptance Tests (UAT) of the Electronic Data Capture (eDC) system and other clinical trial software.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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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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Experience with electronic Quality Management Systems and Trial Master File. Experience in managing or supporting clinical trial or Drug Safety-related regulatory inspections a plus.
$185,000 - $226,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience working effectively with CROs/CSPs. Expe rience with electronic Quality Management Systems and Trial Master File. Skills and Abilities A solid understanding of GCP, GLP, GMPs and CMC requirements is expected.
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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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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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Send back the results (pdf file) 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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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. 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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Trial Master File (TMF) 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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Uploads of Clinical Supply Chain Documents file documents to the electronic Trial Master File (eTMF) May coordinate with other department representatives to identify future business needs.
$55 - $58 an hourExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Hybrid: 3 days a week minimum. The VO QC Specialist is expected to complete tasks and projects under minimal supervision and has the ability to manage competing priorities effectively and proficiently.
ExpandApply NowActive JobUpdated 7 days ago
trial master file jobs in South San Francisco, CA
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