Ref #: 32238

Employment type: Permanent - Full-Time

Location: Seoul, South Korea

Posted: 23-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.
The Global Strategic Solutions team at ICON, formerly DOCS, is a global leading provider of Functional Service Provision (FSP) for a reason. We offer a range of FSP models that drive the most efficient functional design for your organisation. We bring a suite of capabilities, expertise and technology to augment your operations, increase R&D efficiencies and improve the quality of portfolio and patient outcomes. We have deployed more than 60 FSP solutions across all major functions from clinical monitoring and project management through data management, statistical programming and beyond.


Key responsibilities
• Act as liaison between Law Department, regional/country clinical operations personnel, HCC and CGAs/CGA Management during issue escalation.
• Analyze legal issues, obtain legal input and provide risk assessments in order to expedite resolution of complex legal issues in clinical trial contracting process.
• Track inquiries and monitor trends to identify need for additional standardized guidance and work with stakeholders to prepare such guidance for review/approval.
• Work proactively to increase global awareness of group processes and procedures and train and educate stakeholders
• Contribute in the capacity of subject matter expert to applicable intra-departmental functions to ensure consistency and compliance with process, external communications policies (clinical trial agreements, confidential disclosure agreements, informed consent forms, etc.).
• Liaise with all members of clinical team as needed on complex and high risk legal issues in addition to representatives of investigator sites, academic research organizations, contract research organizations, and site management organizations as directed.
• Lead/conduct contract negotiations on high risk terms and conditions and complex agreements and other relevant legal documents related to clinical trials.
• Responsible for independently coordinating assessments from stakeholders such as clinical team, law department, and internal team where appropriate to evaluate risks of legal terms and conditions and guiding preparation of escalation for business decision.
• Liase with legal and internal stakeholders as appropriate to prepare, organize and maintain contract templates in accordance with changes in laws, regulations, or corporate policies.
• Identify and promote best practices. Adhere to SOPs, ethics and departmental compliance as determined by management as well as operating companies, corporate, HCC and QA guidelines.
• Compile, document, and organize regional and country level intelligence related to clinical site contracting.
• This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.

Required experience and qualifications
• More than 1 year of experience in the Pharmaceutical/Clinical Research Industry and/or equivalent competencies in relevant fields
• For a Senior, Must have a working knowledge of the clinical development process with at least 3 years of contract negotiation experience
• Experience in both SSU & CRA preferred (Either will be fine)
• Excellent oral and written communication skills and sensitivity to cross-cultural communication
• Strong relationship management skills and experience
• Ability to work effectively across all levels of management
• Strong and proven issue identification and problem resolution skills
• Sense of urgency with ability to manage competing priorities while meeting deadlines
• Working knowledge of PCs, MS Office and database management
• Business acumen and complex project management skills
• Must demonstrate innovative spirit, strong interpersonal and leadership skills with a strong drive to mentor and coach team member.


To be successful in the role, you will have:

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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