Experienced Clinical Study Manager-Remote - 230243

Company: W.L. Gore
Location: Flagstaff
Posted on: March 16, 2023

Job Description:

About Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.

About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn more at gore.com/products/industries

About the Role: We are looking for an Experienced Clinical Study Manager (CSM) to join the Clinical Affairs Team, and ensure compliance with the protocol, overall clinical objectives, and applicable SOPs and regulations. This will be accomplished through planning, implementing, and managing the overall conduct or particular elements of clinical research projects.

This is a remote position, and you can work from home in most locations within the United States.*

Responsibilities:

• Lead the activities of interdisciplinary Gore team members: plan, execute, and close complex global clinical studies
• Provide study leadership within the project team to foster inclusive teamwork, cooperation and to provide strategic direction on operational study needs
• Responsible to ensure clinical study meets timelines, quality standards and projected cost estimates
• Develop and approve study-specific documents, tools, presentations, and processes
• Oversight of clinical studies to include activities of site monitors, clinical vendors, review and approval of site visit reports, selection and coordination of DSMB / CEC / Steering Committees, and participation in site visits as necessary
• Track and report progress of studies to applicable internal stakeholders, to include patient screening, enrollment, data collection, protocol compliance, device accountability, adverse event documentation and reporting
• Develop Study Reports and provide clinical portions for Regulatory submissions
• Manage non-compliance for resolution and prevention
• Participate in process improvement efforts
• Maintain knowledge of industry and regulatory trends as required to meet business needs and perform the responsibilities of the position
  
  Required Qualifications:
  
  • Bachelor's degree in a science or health-related field
  • Minimum of 5 years experience in clinical research
  • Experience developing clinical trial plans including site monitoring, risk mitigation strategies, trial budgets and site selection/feasibility
  • Experience leading and working on cross-functional teams
  • Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint, EDC, CTMS, eTMF)
  • Strong organizational skills, flexibility, and ability to multi-task
  • Effective verbal and written communication skills
  • Ability to travel up to 30%, including international travel (Travel is primarily U.S. based)
    Desired Qualifications:
    
    • Experience in clinical research, scientific research, nursing, medical device industry or pharmaceutical industry
    • Minimum of 3 years Project Management experience
      *Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's remote working policies, from the country in which they are employed. Locations not eligible for new remote work arrangements include: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).
      
      What We Offer: At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits. Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, health & well-being program with full health plan, and a flexible working program. Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development. Learn more at gore.com/careers
      
      We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect.
      
      Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
      
      Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
      
      Gore is a M/F, Disabled and Vet EEO/AA employer. (Applies to all positions in the U.S.)
      
      Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
      
      #LI-MSL
      
      #LI-Remote

Keywords: W.L. Gore, Flagstaff , Experienced Clinical Study Manager-Remote - 230243, Healthcare , Flagstaff, Arizona