Site Contracts Specialist

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.

We are currently recruiting for an experienced Site Contracts Specialist in Romania to work for a global biotechnology company.

This particular role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs; you will work for a client that values their staff and puts an emphasis on career development.

Responsibilities:

• 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.
• Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
• 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 the team and support functions. Escalate issues as appropriate.
• 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 and operating companies.
• Analyze contract requests/needs from operating companies and translating into appropriate contracts/budgets for company sponsored and investigator initiated clinical trial agreementsand other relevant legal documents as they relate to various clinical projects.
• Ensure that contractual terms and provisions are following corporate process, systems, and strategies.
• May mentor, champion, or represent functional area in process initiatives, as required.

Requirements:

• Bachelor’s degree in appropriate scientific or business disciplines
• 3 years’ experience and/or equivalent competencies in legal/ pharmaceutical industry/clinical research.
• Previous experience in site contracts negotiations in clinical trials
• 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.

Why 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.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.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, 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.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.

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