Ref #: 30426

Employment type: Permanent - Full-Time

Location: Kuala Lumpur

Posted: 06-Jul-2021

Description

Description:

* Responsible for analyzing 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.
•* Provide specialized support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required
•* Analyze investigator grants for fair market value aligned with regional knowledge and the J&J grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information. Participate in and/or lead the approval escalation of grants as appropriate.
•* Provide guidance to CROs contracted to negotiate CTAs globally, inclusive of training and supervision.
•* Determine potential needs for contract amendments and manage amendment life cycle.
•* Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.
•* Work with the global C&G team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language. * Assess risks of budget and legal provisions in conjunction with members of the C&G team and support functions and communicate such to stakeholders. Liaise with C&G management, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.
•* Assume responsibility for all aspects of legal document and metrics tracking.
•* Review, authorize and/or manage payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
*Mentor and train new contract coordinators and analysts

Profile:

•* Bachelor’s degree in appropriate scientific or business discipline
•* 3- 5 years’ experience and/or equivalent competencies in pharmaceutical industry/clinical research
•* Must have a working knowledge of the clinical development process with 2 years of negotiation and contract experience
•* Excellent communication skills (both oral and written)
•* Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) a plus
•* Working knowledge of PCs (MS Office suite at a minimum) and database management
•* Fluency in English is required
•* Previous experience working in virtual teams preferred


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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