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Senior Clinical Trial/Project Manager

Company: US TECH SOLUTION
Location: Irvine
Posted on: October 12, 2020

Job Description:

If Interested please do send me your updated resume - Job Title: Senior Clinical Trial/Project Manager Location: Remote Duration: 06 Months Contract with possible extension Job Description: Under direct supervision of the Global Medical Trial Management (GMTM) Director and Team Lead, the Post-Marketing Trial Manager is responsible for the execution of assigned Phase IV projects. Primary responsibilities of this position include: Responsible as the operational study lead in collaborating with other functions, and responsible for, the execution and delivery of studies (e.g. Medical Affairs, Regulatory Affairs, Biostatistics, Global Drug Safety, Clinical R& D, Epidemiology, Global Clinical Supply, Procurement, Vendor Oversight, Legal, R&D Quality Assurance). Responsible for the execution and adherence of various aspects of the stu operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as company SOPs and policies. Responsible for managing study budget, timelines, and risk mitigation processes. Responsible for managing the selection, contracting and oversight of CROs and other clinical trial related vendors in collaboration with Procurement and key stakeholders. Responsible for ensuring up-to-date trial information is entered into CTM and other required systems. Assist as required with departmental projects and provide recommendations for continuous procedural improvements. Education and Experience B.S. degree (life science or health related preferred). Minimum of 3 to 5 years in the pharmaceutical industry/CRO, which include 1-2 years of clinical/medical research experience, or transferrable skills. Process and system thinking, customer orientation, and ability to work in multidisciplinary study teams and to execute within a matrix management model, ideally in pharmaceuticals/biotech. Experience in execution of clinical research trials, including GCP and regulatory guideline knowledge and audit inspections. Experience in the management of CROs and other clinical trial related vendors. Knowledge and experience in clinical study budgeting including timeline a the application of clinical trial performance metrics. Demonstrated ability to support the development and management of various aspects of the end to end study operational plan. Demonstrated ability to support the operational execution and delivery of various aspects of a quality clinical trial. Program and project management experience preferred. Ideal candidate will have experience in leading and managing interventional, observational, prospective, retrospective trials and/or chart review studies. Migraine and/or Aesthetics experience a plus. International experience a plus. Knowledge, Skills and Abilities Knowledge of drug development and FDA GCP/ICH regulatory guidelines. Strong Project Management Exp. Proficiency with and ability to utilize software applications that suppor Clinical Operations: Microsoft Word, Excel, PowerPoint; Adobe Acrobat, EDC systems, etc. Clinical trial management system (CTMS) background is a plus. Strong ability to work within a matrixed organization, managing multiple tasks in a timely, budget conscious manner. Ability to identify and work with key stakeholders to deliver operational requirements. Ability to identify issues, analyze situations and provide effective solutions. Strong oral and written communication skills. Ability to multi-task and execute under tight timelines. * Ability to embrace change and comfortable with ambiguity. Show moreShow less

Keywords: US TECH SOLUTION, Irvine , Senior Clinical Trial/Project Manager, Healthcare , Irvine, California

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