Legal Clinical Contract Manager

Company: W.L. Gore & Associates
Location: Phoenix
Posted on: November 19, 2023

Job Description:

About the Role: We are looking for a Clinical Contract Manager Associate to join our Legal team. In this role, you will be responsible for meeting the contractual needs for clinical studies within the Medical Products Division.

This position will be located at one of our facilities in either Phoenix or Flagstaff, Arizona, Newark, Delaware, or Elkton, Maryland, with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.

Responsibilities:

• Partner with business teams to evolve and execute contracting strategy
• Drive the contract management process including drafting, business reviews, negotiating, execution, and budget terms to ensure consistency with Gore's business and legal requirements within the U.S. and abroad
• Serve as primary liaison with site contracting representatives to coordinate, administer and monitor contracts through execution
• Coordinate with and advise internal clients on various contractual provisions and issues and communicates information to stakeholders about contract-related matters
• Seek legal and/or regulatory advice when needed to assist in contract execution and negotiation
• Monitor and track active agreements
• C ompile and analyze contract data and establish contract metrics
• When appropriate, provide input into process improvements for the management of executed contracts and templates
• Provide input and guidance to Clinical Affairs and other MPD functions on initiatives, goals, policies, and procedures relating to clinical contracting activities
• Interact and collaborate with Clinical Affairs, Regulatory, Finance, Compliance, and attorneys to ensure timely and accurate contract preparation and problem resolution
  
  Required Qualifications:
  
  • BBA, BA or BS Degree and m inimum of 5 years experience as a contract specialist/contract manager with demonstrated ability in contract administration, negotiation and management supporting clinical affairs and research, or in the medical device, pharmaceutical or healthcare industry
  • Drive complex budget development in close collaboration with business stakeholders as needed
  • Experience working in cross-functional and virtual teams, ideally across cultures and regions
  • Experience establishing process improvements across multiple functions to meet regulatory and customer requirements
  • Proficiency in Microsoft Suite with strong, demonstrable capabilities with excellent interpersonal and communication skills (both verbal and written)
  • Ability to work with sites and find solutions to meet regulatory requirements while protecting company Intellectual Property
  • Proven ability to analyze complex contracts and the resulting business risks and communicate them broadly to leadership
  • Ability to function independently and in a self-directed manner, while at the same time within a highly cooperative team environment
  • Ability to seek and incorporate legal advice and to work under the direction of counsel
  • Ability to travel up to 5%
    Desired Qualifications:
    
    • Experience in the medical device industries or clinical research
    • Self-starter with the ability to work independently and with teams
    • Experience working with clinical study agreements in multiple countries
      Hybrid Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's hybrid working policies, from the country in which they are employed.
      
      What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
      
      We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefits
      
      We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
      
      Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
      
      Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.
      
      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.
      
      Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact

Keywords: W.L. Gore & Associates, Phoenix , Legal Clinical Contract Manager, Legal , Phoenix, Arizona