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Outsourcing Associate
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Manager Vendor Outsourcing
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Clinical Contracts Associate
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Clinical Outsourcing Manager
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Clinical Contracts Associate
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Clinical Research Associate
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Clinical Contract Associate
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Courier/delivery Driver
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Mailroom Associate
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Client Delivery Executive
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Administrative Coordinator-berkeley
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Client Delivery Executive
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Facilities Tech Manager
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Operations Manager 29356
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Global Commodity Manager
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Gilead Sciences, Inc. Foster City, CA, United StatesFor Current Gilead Employees and Contractors: · Please log onto your Internal Career Site to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - workin ...
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Research Associate II
1 week ago
R&D Partners Foster City, United StatesJob Description · Job DescriptionBiotechnology company is hiring a Research Associate II within the Pathobiology department to contribute to histology and pathology workflows in support of pre-clinical in vivo pharmacology studies. This position will support drug development in d ...
Clinical Vendor Outsourcing associate - Foster City, United States - Intelliswift Software
Description
Title: Clinical Contracts Associate – I (VQ Associate I)
Location: Foster City
Duration: 12 Months on W2
Hybrid: 3 days a week minimum
Details:
The candidate should have a deep understanding of vendor outsourcing's responsibilities throughout the vendor sourcing, contracting, and management processes as they will be reviewing VO's functional responsibilities in support of the clinical development portfolio. 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.
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.
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.
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.
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.
Demonstrates a thorough understanding of current global and regional trends in compliance. 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
Skills:
• Strong interpersonal communication skills
• Attention to detail and proactive management of quality findings will be integral to the team's success
• Strong project management, organization, and critical thinking skills
• Comfortable interacting with internal stakeholders and external vendors
• Executive presence
