Senior Clinical Study Manager - 100% Remote, US

Company: NAMSA
Location: Austin
Posted on: January 16, 2022

Job Description:

North American Science Associates (NAMSA) started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976, thus pioneering the industry. NAMSA was the first independent company in the world to focus solely on medical device materials for safety. Join our company's global expansion as we continue to provide support for clients during every step of the product development lifecycle and beyond.
Sr. Clinical Study Manager Position Summary
As a Senior level Clinical Study Manager you are a member of the Clinical Services group. This high profile role requires a clinical trials expert to manage all aspects of global clinical trials, including budgeting for the entire study, oversight of full-service operations, along with the technical and therapeutic aspect of the trials. You are a creative problem-solver, with strong attention to detail, flexible to change, and possess an ability to effectively multi-task. Qualify or advance within this role of strategic and multifaceted levels, i.e., Clinical Study Manager, Sr. Clinical Study Manager, Principal Clinical Study Manager and Sr. Principal Study Manager. Opportunity for learning and growth is available within the group and throughout NAMSA.
Day-to-day responsibilities include:

• Establishes and ensures schedule, budget and quality commitments are met for the client.
• Manages (motivates, communicates) internal team members.
• Understands investigational product(s) including high-level understanding of the Medical Device Development Process.
• Handles challenging situations, and knows when to call-in help.
• Interacts as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
• Performs project in compliance with regulations.
• Delivers presentations, including preparation, assembling slides, and speaking.
• Provides feedback regarding project team members using the appropriate performance management tools and processes, in a timely manner.
• Effectively manages cross-functional projects.
  
  Other duties may include, depending on job level and project/business need:
  • Clinical site selection and qualification; clinical site initiation and training.
  • Clinical monitoring plan development.
  • Clinical monitoring strategy; troubleshoots site and team issues.
  • Follows up and closes (whenever possible) issues/action items found during monitoring. Tracks and manages enrollment; troubleshoots enrollment challenges.
  • Assists team members in managing challenging investigators/staff.
  • Provides oversight of team members to ensure regulatory and monitoring documents are audit-ready throughout conduct of study.
  • Manages development of a simple clinical study report.
  • Conducts and summarizes literature searches according to applicable US and EU requirements.
  • Assists in planning and conduct of site and sponsor clinical audits (Pre-BIMO).
  • Assists with FDA CRO inspections of NAMSA.
  • Organizes and manages Investigator Meetings.
  • Selects and manages Core Laboratories.
  • Safety committee (e.g. DSMB or CEC) selection and management.
  • Works with data management to develop systems for and track project metrics.
  • Works with data management/biostatistics to develop reports and listings for centralized review of data; reviews data, spots trends to ensure quality of data.
  • Moderately complex clinical study design and clinical protocol development.
  • Leads moderately complex multidisciplinary (stats, DM, clinical) US and OUS clinical projects.
  • Performs as lead auditor for site and sponsor clinical audits (Pre-BIMO).
  • Identifies and implements solutions to accelerate enrollment.
  • Manages a moderately complex clinical study report.
  • Interacts directly with FDA.
  • Negotiates with regulatory agencies and clients.
  • Participates in meetings with prospective clients.
  • Provides scope of project and relevant information to support the creation of proposals.
  • Identifies opportunities to bring in new projects/clients.
  • Offers opportunities to clients for expansion of MRO services to be provided by NAMSA.
    
    Minimum Requirements:
    • Bachelor's degree or equivalent experience in a related field, with a minimum 5 years of monitoring (preferred) and relevant clinical trial experience; and
    • Project management experience with at least 1 complex multicenter US/OUS trial.
    • Fluency in English and local language, if different, required.
    • Knowledge and experience with applicable standards and regulations for medical device trials.
      *More job description detail is provided on the NAMSA Careers page: https://namsa.wd5.myworkdayjobs.com/NAMSA/job/Remote---USA/Clinical-Study-Manager_R1854
      NAMSA is a responsive employer offering competitive benefits packages, exceptional training, opportunities for growth, and more - wrapped up in a meaningful career. Please apply with your LinkedIn profile for a thorough review and an immediate phone discussion.

Keywords: NAMSA, Austin , Senior Clinical Study Manager - 100% Remote, US, Executive , Austin, Texas