Site Contracts

Keelira is the early clinical development services business of Ryvu Therapeutics. Built within a drug developer, it brings a sponsor perspective to oncology and hemato-oncology development across Europe, with a core focus on clinical entry through Phase II.

We are looking for a Site Contracts & Budgets Manager to build and own our site contracting function, supporting early-phase oncology and hematology studies across Europe, from clinical entry through Phase II.

In this role, you will negotiate clinical trial agreements and site budgets, establish practical contracting standards, oversee external negotiators and ensure that agreed payment terms can be implemented by Finance.

This is initially a hands-on individual contributor role, with the opportunity to build and lead a small team as our study portfolio grows.

KEY RESPONSIBILITIES

• Prepare, negotiate and finalize clinical trial agreements, site and investigator budgets, and amendments across Poland, Spain, France and Italy, and other countries as required.

• Negotiate budgets against the protocol, fair market value benchmarks and client budgets, covering overheads, fees, pass-through costs and screen-failure rules.

• Define clear, workable payment terms, including payment triggers, invoicing responsibilities, advances, holdbacks, reconciliation and final settlement.

• Coordinate legal, clinical and financial input, resolve comments within agreed negotiation positions and elevate issues requiring a decision.

• Provide site cost estimates for proposals and bid defenses, keeping site budgets aligned with client budgets and relevant regulatory submission information.

• Establish working rules for CROs and external consultants, including templates, fallback positions, negotiation authority, review standards and response times.

• Review outsourced contracting work, track progress and address delays, quality issues and recurring problems.

• Coordinate approvals and signature, verify the completeness of executed agreements and maintain an accurate contract repository.

• Hand over agreed payment terms to Finance for implementation in the CTMS payment module and help resolve site payment queries.

• Build and maintain country templates, a negotiation playbook, budget benchmarks, contract trackers and performance metrics.

• Introduce practical tools, including AI-assisted review with human oversight and appropriate protection of confidential information.

• Develop the case for bringing additional contracting activities in-house and recruit and develop team members when study volume supports it.

YOUR BACKGROUND

• At least five years (ideally five to eight) of experience negotiating clinical trial agreements and site budgets at a CRO, sponsor or site network, including at least two to three years across several EU countries.

• Hands-on experience with Polish public hospitals, medical universities and research institutes and their contracting and payment practices; experience in Spain, France or Italy is an advantage.

• Working knowledge of ICH-GCP (E6(R3)), the EU Clinical Trials Regulation, GDPR in clinical research, the Polish Clinical Trials Act of 2023 and national templates such as the French convention unique and the Italian national contract.

• Experience building site budgets against fair market value benchmarks and designing payment terms that a payment system can execute.

• Experience overseeing CRO site contracting or external negotiators; people management experience is an advantage.

• Ability to negotiate independently and firmly, maintain constructive relationships with sites and recognize when to elevate.

• A structured and precise approach, with the ability to triage comments quickly, maintain a single consolidated version of each agreement and keep accurate trackers.

• Ability to build practical tools and processes, including AI-enabled workflows, and support their adoption by colleagues.

• A degree in Law, Business, Finance, Life Sciences or a related field.

• Fluency in English and Polish; Spanish, French or Italian is an advantage.

YOUR BENEFIT PACKAGE

• A role that builds a function from the start in a growing clinical development business backed by a drug developer.
• Employment contract with Ryvu Therapeutics S.A. (B2B also possible).
• fully remote work from anywhere in Poland.
• Ryvu employee benefits, including private medical care, a Multisport card and English classes.
• As Keelira grows, the role is expected to lead a small team of site contracts specialists, and its title and scope will be reviewed as that team is built.