Senior Associate

2 weeks ago

Reading, United Kingdom ICON Full time

It is a very exciting time at ICON - we’re a world-leading healthcare intelligence and clinical research organisation. 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.

2024 will be starting very positively - a number of new projects in our client’s portfolio means that we are augmenting our Contracts/Budgets team. If you have experience with clinical site contract management (or negotiation activities) we would love to hear from you.

You can either from home or at our client's Cambridge office.

Purpose

Provide clinical site contracting services to clinical study teams to support study start up and conduct activities

Context and Responsibilities

Reports to: - Clinical Trial Operations Manager.

**Responsibilities**:

- Manage end to end process for clinical site contracts and clinical trial related consulting agreements (including contracts, amendments and termination letters preparation, negotiation, escalation, translation, distribution, signature, archiving).
- Support site-related questions regarding invoice preparation with respect to submission of invoices in Client Payment System (eGPS)
- Support resolution of contract issues
- Support contracting with local GSO vendors
- Maintain contract tracking in appropriate systems
- Manage Confidential Disclosure Agreement process
- Identify opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness
- Ensure payments are made in accordance with contracts
- Maintain payment data tracking in appropriate systems
- Responsible for providing information for entry into systems

Key Activities

Negotiate site contracts from the contract templates using appropriate guidelines, and collect necessary signatures for contract execution
- Negotiate site budgets from base budget and payment milestones using appropriate guidelines; complete final Schedule A for addition to contract
- Escalate contract and budget issues to Legal or Clinical Pricing & Payments Group and GCPM as appropriate to ensure Fair Market Value compliance
- Set up financial data, raise purchase orders and handle appropriate entries/requests into relevant financial and payment systems (eFinity, MyBuy, SAP). Support Clinical Pricing & Payments Group in setting up sites for eGPS or legacy systems.
- Track contract progression using appropriate systems
- Amend and terminate contracts as necessary throughout lifecycle of study
- Store and archive contracts and budgets in appropriate systems
- Maintain payment records and provide assistance with audit review records
- Responsible for reviewing and approving, with Law guidance, applicable changes within ICF part 2.
- Responsible for the contracting process and/or point-of-contact for vendor for locally outsourced studies
- Responsible for the Clinical Trials Insurance process
- Participate in appropriate site/legal meetings as required to resolve contract issues
- Participate in appropriate site/finance meetings as required to resolve payment issues
- Maintain party information and contract activation in Contract Generation System
- Approve or reject clinical invoices
- Process and track Confidential Disclosure Agreements as appropriate
- Manage contracting process with Clinical Trial Related Consulting Agreements
- Manage all study-related Site payments not managed by Clinical Pricing & Payments Group

Key Relationships

Vendors - Site Legal/Financial Staff - LOC staff - Site Clinical Staff - Legal - Finance - GCPM - Global Clinical Pricing

Decision Making Authority

Decision to escalate issues and/or involve legal or GCP & GCPM

Agreement of budgets/ milestones and contracts within parameters

Outputs
- Finalized contracts and budgets
- Executed contracts
- Status reporting and updates
- Payment execution
- Confidentiality agreement

Experience working in NHS (NIHR) or in a commercial role in a contracts/budgeting role.

Degree or equivalent.

Based in the UK - with the requisite right-to-work already in place.

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