Contracts Associate - CDA Specialist - Remote USA

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

GENERAL POSITION SUMMARY:

The CDA Representative works directly with clinical sites, vendors, and Vertex legal on the negotiation of the Confidentiality Disclosure Agreements (CDAs). 

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS

• Refer to key responsibilities section below
• Strong communication (written and verbal) skills to be able to interact with internal Vertex groups as well as external groups
• Strong attention to detail
• Ability to work in a matrix, cross-functional team
• High level understanding of clinical trial contract and budgeting process
• Ability to quickly ascertain and relay the needs of Investigative Sites/Site Staff and their Institutional requirements
• Ability to quickly identify, communicate about and propose solutions for any site issues that may arise

KEY RESPONSIBILITIES:          

• Serve as primary point of contact with Investigative Sites or Vendors for CDA negotiations
• Collaborate with Vertex Legal for any contract language negotiations
• Adhere to CBM policies and procedures for CDA negotiations
• Perform CDA Coverage Analysis checks to determine if coverage exists
• Filing in CTMS and entering metadata based on information from the CDA
• Perform quality checks of metadata within CTMS and other electronic repositories
• Document all CDA activities in CTMS and maintain milestone data
• Liaise with appropriate stakeholders to address and resolve site or vendor queries
• Attend and contribute to study related meetings, as required
• Manage site and vendor relationships to high standards of excellence
• Maintenance of the CDA documentation folders
• Maintain site communication within established timelines for the study or program
• Assist in key initiatives, as requested (peer buddy, CDA team, SME)
• Other duties as applicable

PREFERRED EDUCATION AND EXPERIENCE:

• BS. or Advanced Degree (or equivalent degree/experience in the opinion of the Hiring Manager)
• Minimum of 1-2 years of relevant work experience
• Works independently; analyzes and enhances strategies used for working with project teams and engaging with client sites.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.