Contract Analyst

Prepare, negotiate and finalize agreements and budgets related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing, planning, execution and control of site/investigator budgets and contracts.

What you will be doing:

Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, etc.
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 the J&J 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 CCS team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of the CCS 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.

CCS management and functional CCS support teams such as, legal, Healthcare
Compliance (HCC), Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.

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.
Adhere to SOPs, ethics and departmental compliance as determined by GCDO management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with CCS, GCDO and operating companies. Comply with requests from
QA and auditors.

You are:

3 years’ experience and/or equivalent competencies in legal/ pharmaceutical industry/clinical research.
Excellent communication skills (both oral and written).
Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harboretc.).
Familiarity with clinical research processes.
Ability to work effectively in cross function teams.
Able to work independently as well as in a collaborative team environment.
Strong and proven negotiation and problem resolution skills.
Working knowledge of PCs (MS Office suite at a minimum) and database management.
Fluency in English.
Must demonstrate innovative spirit, have strong interpersonal skills, ability to manage a high volume of work.

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/benefits

At 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-accommodations

Interested 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.