Ref #: 33708

Employment type: Permanent - Full-Time

Location: Ukraine

Posted: 18-Nov-2021

Description

If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance.
We are hiring a Clinical Research Associates and Senior CRAs to work closely with our client, a leading pharmaceutical company.

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

Overview:
In this role you will prepare, negotiate and finalize agreements and budgets related to clinical trials and/or overseeing a Clinical Research Organization (CRO) responsible for contract negotiations. This position can be home-based.

Key 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.
• Work with global teams to review and analyze contractual terms and conditions.
• Assess legal and budget risks in conjunction with team support functions.
• Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
• Manage the contract amendment lifecycle.
• 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.
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. SATS) according to expectations (metrics) and archiving retention requirements.
• Analyze contract requests/needs from operating companies and translating into appropriate
contracts/budgets for company sponsored and investigator initiated clinical trial agreements
and other relevant legal documents as they relate to various clinical projects.

Required experience and qualifications:
• Bachelor’s degree in appropriate scientific or business disciplines
• 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 Harbor, etc.).
• 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.
Fluency in 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.

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