Senior Site Contract Analyst

Overview

Senior Contract Analyst

Location: Home-Based, Australia

As a Contract Analyst you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Within this program you will thrive within a fast-paced, dynamic study design. As we are fully embedded with this global pharmaceutical client, you will experience a true “one team” approach that provides limitless opportunity to develop through training, mentorship, and support from leadership.

Responsibilities

What you will be doing:

• Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations. Responsible for delivery on established targets/measurements.
• Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Escalate as appropriate.
• Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and pricing guidelines. Participate in and/or lead approval escalations as appropriate.
• Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
• Participate in discussions related to the development of site/investigator budgets aligned with fair market value.
• Manage the contract amendment lifecycle.
• Work with the global team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of thee team and support functions. Escalate issues as appropriate.
• Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
• Assume responsibility for all aspects of legal document and metrics tracking.
• Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
• Track all aspects of legal document and metrics. Determine potential needs for contract amendments and manage amendment lifecycle.
• Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management according to expectations and archiving retention requirements.
• Ensure inspection ready and comply with relevant training requirements and developing therapeutic knowledge to ensure service delivery.

Qualifications

You are:

• It would be nice to have IIS experience

• Negotiations of complex agreements (ie. study level or master agreements between industry sponsor and CRO)

  project management of 15-20 competing projects, negotiators of large scale budgets (budgets here are at the study level and range from 50-300MM)

• Soft skills: self motivated, excellent communication, excellent collaboration, aptitude for solution oriented/strategic thinking, documenting/presenting risk assessment and mitigation strategies, ability to apply key principles (such as we are not the sponsor and must limit influencing sponsor to our vested interest in the study drug and ensuring the study is conducted in a manner that promotes subject safety in light of our special knowledge of the product).

• Language Skills: Fluency in English (mandatory) and preferrably in one of the following language (Mandarin, Japanese, Korean)

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.