PRAHS Hiring for Contracts Associate 3 at United States Full Time

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.

• Develop Clinical Trial Agreements (CTAs) utilizing standard templates and information from Contract Information Sheets.

• Ensure CTAs are executed in a timely manner in order to meet expected timelines for study start-up.

• Liaise with the legal departments of both Bayer and contract parties to ensure any content changes to the CTAs are mutually agreeable, and in accordance with Bayer’s legally approved standard agreement language.

• Participate in Study kick-off meetings to obtain necessary information required for effective CTA execution.

• Solid understanding of standard contract language to enable decision making pertaining to sections of CTAs when language modifications are proposed by external contract parties.

• If language is not compliant, discuss issues with legal and work with the legal department, sites, contractors or vendors to resolve them.

• Generate site budgets based on final approved country budget in preparation for distribution to sites and following up with investigators.

• Research medical procedure costs using local or global database in order to provide accurate data for development of the site level budgets to allow Country Lead Monitors/Study Managers to calculate the latest average costs on procedures for their new studies.

• Manage CTAs ensuring all changes to agreements and corresponding components are updated according to Bayer legal standards and Bayer Global SOPs.

• Responsible to ensure annual review of all templates with the Legal department and Local Head of Monitoring and Site Management

• Manage the contract tracking database, including coordination of timely updates with respect to CTA.

• Ensure accuracy of information and reconcile discrepancies between documents and the database.

• Responsible for posting of fully executed contracts in eFiliA and locally on the Clinical Operations secure drive.

• Process for each study, internal approval forms and other documents which are required to ensure compliance with the Internal Signatory Process and are also required for annual audits.

• Ensure excellent communication and collaboration as point person among clinical trial site personnel (Investigator, Study Coordinator, Institution’s Legal Counsel) Bayer’s Head, Clinical Operations, Legal Counsel and Manager, Insurance, throughout the contract negotiation process.

• Responsible for preparing for internal audits by maintaining a complete and accurate paper trail for each site contract negotiation.

• Negotiate Master Services Agreements (MSAs) with Institutions where Clinical Trials have been conducted and ensure they are reviewed prior to their renewal dates

Key responsibilities will include:

• Negotiation and on-going management of clinical trial agreements with investigative sites.

• Accurate forecast of contract execution timelines in support of timely site start up for the conduct of clinical trials

• Communicate and explain legal/ budgetary issues to internal and external parties per department guidelines and ensure country specific laws and regulations are followed.

• Review and evaluate client requested contract changes and based upon department guidelines escalates deviations as appropriate.

• Appraises contracts for completeness and accuracy and ensures adherence to department guidelines; corrects documents and files changes to contracts.

• Interact and collaborate with other functional areas, including other study-start up colleagues and CRAs

Must have a Bachelors’ degree or an equivalent scientific or commercial Higher Vocational education with preferably experience in the healthcare field, pharmaceutical industry or clinical research

You have an adaptable working style with the ability to establish and reset priorities as the need arise. Risk-aware, you can adjust quickly to the changes of a dynamic organisation.

Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

• Bachelor’s degree or higher

• Experience working in contract administration with an understanding of legally binding agreements

• Ideally you will have experience of negotiating Clinical Trial Agreements with clinical research sites

• Fluency in written and spoken English

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.

ID: 2022-97223

External Company Name: Pharmaceutical Research Associates, Inc

External Company URL: http://prahs.com/

Location: US-Remote