Contract and Budget Negotiator
- Employer
- ICON Strategic Solutions
- Location
- Israel, Homeworking
- Salary
- Competitive
- Start date
- 4 Feb 2023
- Closing date
- 5 Mar 2023
View more
- Discipline
- Clinical Research, Clinical Operations, Clinical Trials Manager / Administrator
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
- 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.
ICON Strategic Solutions (ISS) is looking for qualified candidate to perform the investigator site contracting Services hereunder in order to support a broad range of therapeutic studies across all our sponsor´s divisions in accordance with the requirements described in FSP Program.
JOB FUNCTIONS/RESPONSIBILITIES
- Perform negotiation of legal terms and budget terms for Clinical Study Agreements (“CSA”) (i.e., investigator site agreements)
- Perform negotiation of legal terms and budget terms for amendments to CSAs
- Draft and negotiate ancillary site contracts (e.g. PI / Sub-I / department agreements /Study Coordinator) as required
- Utilize Sponsor´s provided templates. Sponsor´s requires stand-alone site contracts with the exception of the US, which utilizes master clinical study agreements.
- Produce and maintain site-specific templates where needed to support the Sponsor´s targeted investigator site list, but limited to the sites within the studies assigned
- Recommend country-specific and site /entity-specific modifications to templates based on site and local regulatory requirements
- Utilize previously negotiated terms for existing contracts between same site/entity and Sponsor´s
- Perform submission and oversight of site and study specific local language translations. Candidate will be required to use Sponsor´s preferred translation vendors. Sponsor´s will manage template version control and translations
- Attend weekly study team and country meetings, as needed
- Identifies risk and mitigation strategies as it relates to meeting contract negotiation timelines
- ICON’s Legal team may provide support to ISS personnel. For the avoidance of doubt, ISS is not providing legal advice to Sponsor´s in any capacity.
- Follow Sponsor´s’s legal guidance document and comments and fallbacks
- Identify contractual and compliance risks for CSA contracting and raise to Sponsor´s
- Collect information from investigator site to complete Foreign Corrupt Practices Act (FCPA) form and submit to Sponsor´s
- Prioritize to meet study timelines to minimize impact to planned Site Initiation Visit (SIV) dates.
- Act independent of CRO managing the study
- Perform quality control checks of contracts and amendments prior to upload to DocuSign for electronic signatures
- If electronic signatures are not permissible, provide management of hard copy/ local signature process
- Contractual Parties:
- Ensure signatory to CSA is authorized to sign on behalf of the party
- Ensure signatory to the CSA will either be responsible for the contractual obligations or operating under a Power of Attorney binding a Sponsor´s entity to the obligations. Sponsor´s preerence is to have Sponsor´s or Sponsor´s Affiliates as the contracting entity for CSAs where possible
- Ensure country - specific singnatory requirements are met (e.g., Some countries require signature by local affiliate (e.g. Italy and Canada))
- Support and provide country level intelligence into the selection of signing part at the country level which must consider payment impact, tax issues (VAT/R&D/WHT) establishment (I.e. corporate presence) and relationship to sponsor.
- Collection and submission of payment support forms, including, but not limited to Payee information forms and required tax forms
- Budget negotiation specific requirements:
- Pre-populate site-specific budget items from prior negotiations following Sponsor´s provided guidelines.
- Negotiate site budgets following Sponsor’s principles document and comments & fallbacks
- Actively participate in per-subject cost development meeting. ISS personnel will provide review and input into the country specific budget templates to minimize timelines for site budget negotiations.
- Provide country level expertise to budget related contract terms and conditions
- Escalate out of parameter budget items to Sponsor´s Investigator Contracts Lead (ICL)
- Record negotiated changes to patient compensation information and provide to Sponsor´s designated contact for Informed Consent Document (ICD)
- Demonstrate effective time management skills; able to independently prioritize multiple tasks.
- Demonstrate the ability to work independently and use initiative to anticipate/resolve issues and complete tasks.
- Shows a commitment to and demonstrate the ability to consistently perform high quality work with minimal management oversight.
Contract Management System:
- Ariba Contracts Workbench is the current Sponsor´s contract management system.
- ISS personnel will utilize the system for all contracts consistent with Sponsor´s provided guidance and training.
Signature processing:
ISS personnel should first adapt and advocate for Sponsor´s-preferred DocuSign system for electronic signature process. Other options / alternatives may be presented by the ISS personnel and will be reviewed by Sponsor´s
Trial Master File:
ISS personnel will file CSA and Amendments into the eTMF within required timeframe
EDUCATION REQUIREMENTS
- Bachelor’s Degree or international equivalent in business, finance, health sciences or related field
- Read write and speak fluent English; fluent in host country language required.
- 1-2 years Industry experience managing contracts required.
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.
Company
As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond.
ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world’s leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact.
Why choose a career with ICON Strategic Solutions?
Meaningful Work: You’ll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives.
Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally.
Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently.
Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization.
Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.
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