Ref #: 32211

Employment type: Permanent - Full-Time

Location: Israel

Posted: 21-Sep-2021

Description

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.

Services Overview:
Prepare, negotiate and finalize agreements and budgets related to clinical trials. Provide support to the clinical team in the pricing, planning, execution and control of site/investigator budgets and contracts.

Deliverables:
-Services rendered will adhere to applicable Sponsor's 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. Responsible for delivery on established targets/measurements.
-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.

Requirements:
-At least two years of experience in contract negotiations
-Bachelor’s degree in appropriate scientific or business disciplines
-Excellent communication skills (both oral and written).
-Familiarity with healthcare compliance and other relevant guidance
-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.

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 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 through the form below.

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