Senior Contract Analyst
- Poland
- Clinical Trial Support
- ICON Strategic Solutions (FSP)
About the role
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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.
As a Contract Analyst you will work with cross functional team members on development of the study CTA/budget templates and escalation of language or costs that cannot be agreed to in the negotiation process. The Contracts Analyst ensures that all site contracts and site specific budgets are negotiated for a clinical study.
What you will be doing:
- Facilitate development and maintenance of CTA and budget templates with CBM, study team, and legal
- Training and mentoring of site contracting representatives on study templates and CTA/budget processes
- Lead study site contracting kick-off meetings
- Review/approve study trial activation plans in collaboration with FASTR
- Provide input to site activation timelines with input from SC Reps
- Ensure SC reps are on track for CTA projections and escalating when appropriate to TA Lead and Regional Managers as applicable
- Serve as primary point of escalation for SC Reps on contract and budget negotiations for the study
- Liaise with sponsor Legal, Clinical Trial Management, FASTR, CBM, RWE, IIS and CRO (if applicable) to address and resolve site escalations
- Ensure amendments to CTAs/budgets related to protocol amendments are finalized within agreed upon timelines
- Keep study team members and Site Contracting Management aware of urgent issues and status updates that may adversely impact study start up timelines
- Review CTMS reports to ensure comments and status of CTAs are updated regularly and escalate noncompliance to Site Contracting Regional Managers
- Represent site contracting team in appropriate meetings on CTA/budget status
- Ensure alignment and efficiencies between parent and rollover studies as applicable
- Ensure other ancillary agreements are completed as applicable (pharmacy, CDA, LOA)
You are:
- 3 years’ experience and/or equivalent competencies in legal/ pharmaceutical industry/clinical research.
- Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.).
- Familiarity with clinical research processes.
- Able to understand, clearly articulate and defend template budget decisions and rationales
- Thorough understanding of budgeting process and able to summarize high-level feedback
- Able to learn quickly about the needs of Investigative Sites/Site Staff and their Institutional requirements
- Can identify, communicate about and propose solutions for any site issues that may arise
- Excellent communication skills (both oral and written).
- 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.
- Working knowledge of PCs (MS Office suite at a minimum) and database management.
- Must demonstrate innovative spirit, have strong interpersonal skills, ability to manage a high volume of work.
- Fluency in English & Local language (French)
Why 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.
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.
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, colour, 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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Principal Talent Acquisition Business Partner
- Icon Strategic Solutions
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