Clinical Trial Manager Post Marketing Phase IV Trials (Remote)

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.

• 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 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.