Contract and Submissions specialist.
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.
We are looking fora Clinical Contract Analyst who has experience in execute and oversee clinical trial country submissions and approvals, contracts and budgets.
What you will be doing:
Manage Clinical Contracts and Nondisclosure Agreement (NDA) process for Global trials:
▪ Serve as a conduit between Clinical Operations and the Legal group for contract requests including Confidentiality Agreements, Clinical Trial Agreements, Ancillary Services Agreements, Consultant Agreements and other clinical contracts.
▪ Process all clinical contract requests and help facilitate early execution through the Contract Management System.
▪ Serve as primary contact for Client during contract negotiation phase.
▪ Perform consistent quality audits of work output and document knowledge base as needed.
▪ Maintain contract tracking on SharePoint site and other systems used to manage contract and budget files.
Negotiate Clinical Site Contracts & Budgets
For Sites Managed by Client:
▪ Manage and own the contract process through its lifecycle from initial template stage to fully negotiated contract.
▪ Work closely with study teams to develop country budget templates tailored for each study.
▪ Negotiate and manage consistent site budgets that will assist in early site activation.
▪ Ensure consistency in site payment schedules and terms to facilitate the payment system.
▪ Respond to queries related to contracts and budgets.
▪ Manage the contract escalation process to appropriate individuals, as needed.
▪ Establish good customer relations with sites starting with the primary point of contact for budgets and contracts.
▪ Analyze contract trends using available tools and assist with developing team metrics with regard to contract timelines.
For Sites Managed by a CRO:
▪ Review and approve the master Investigator Fee template developed by CRO for each study before distribution to sites
▪ Manage the final execution of site clinical contracts handled by a CRO and track the contract process for each study with a CRO.
▪ Serve as escalation point of contact for budget escalations from CRO.
▪ Provide contract/budget comments to CRO on an as needed basis.
▪ Respond to CRO queries for previously negotiated site contracts to ensure consistency with contract language and budget line items.
Execute and oversee clinical trial country submissions and approvals.
▪ Develop written processes relevant to the scope of work listed above as needed.
▪ Contribute to team efforts for continuous process improvements.
▪ Adhere to Clinical Operations or project specific quality documents (e.g., SOPs, work practices, training guides), as applicable.
▪ Participate in the development and testing of relevant tools and procedures.
▪ Workflow management.
Education and Experience
- Bachelor’s degree in Life Science, Business or equivalent.
- Minimum 3 years of global experience working in a biotech or CRO, finance and/or business environment as a contract analyst/specialist.
- Experience negotiating contract payment terms and clinical budgets and submissions.
- Intermediate Excel and database management skills.
- Knowledge of GCP/ICH requirements.
- Excellent analytical and problem solving skills.
- Requires effective organizational and communication skills.
- Work both independently and ability to successfully work in a “virtual” team environment.
- Has a track record of exceeding goals successfully.
- Partners with others to get work done.
- Follows through on commitments.
- Shows personal commitment and takes action to continuously improve.
- Deals constructively with problems that do not have clear solutions or outcomes.
- Maintains a positive attitude despite adversity.
- Acquires data from multiple and diverse sources when solving problems.
- Fluent in Italian and English.
- Must have sponsor side experience negotiating clinical trial contracts and clinical budgets with Sites
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.
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