Job Details

ID #17184007
State California
City Irvine
Job type Contract
Salary USD BASED ON EXPERIENCE BASED ON EXPERIENCE
Source Alpha Consulting Corp.
Showed 2021-07-23
Date 2021-07-22
Deadline 2021-09-20
Category Science/biotech
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Clinical Trial Manager Post Marketing Phase IV Trials (Remote)

California, Irvine, 92612 Irvine USA

Vacancy expired!

CLINICAL TRIAL MANAGER POST MARKETING PHASE IV TRIALS (REMOTE)IRVINE, CA Please note and be aware that this position is a fully Remote, Field Office-USA position, however we are open if by chance the worker would like to work on-site in Irvine, CA if needed. Project Description: Under direct supervision of the Evidence Solutions Director for Aesthetics, the Post-Marketing Trial Manager is responsible for the execution of assigned Phase IV projects. Job Responsibilities:

  • 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 study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including Google Cloud Platform, 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 CTMS 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 includes 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 Google Cloud Platform 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 and 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 Google Cloud Platform/ICH regulatory guidelines.
  • Proficiency with and ability to utilize software applications that support 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.
This 12+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #21-02376MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE #ZR#LI-BB1

Vacancy expired!

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