Site Budget and Contract Specialist (Poland)

About the Role

The Site Budget and Contract Specialist is a key member of the Site Selection and Contracting team. This person works closely with project teams as well as the legal / contract department in the preparation, negotiation and execution of budgets and contracts (clinical trial agreement – CTA) with investigator sites across EU, North America and other countries.

Ideal Profile

• You can easily achieve consensus while maintaining positive working relationships with external partners
• Your team can count on you to get things done
• You have an ease to work with numbers (standardized budgets)

Responsibilities

Contracts and Budgets Preparation

• Obtains the minimum and maximum site budget prepared by Business Development and approved by the Sponsor
• Obtains the project-specific site CTA template from Legal Affairs and Contracts approved by the Sponsor
• Prepares the contract schedule (study information, timelines and payment information) in collaboration with the Project Manager
• Prepares and sends the Sponsor-approved contract and budget to sites for review

Contracts and Budgets Negotiations

• Manages budget negotiation with the sites to ensure budget remains within the Sponsor-approved limits and escalate issues as necessary
• Manages contract negotiation with sites and escalates legal language requests to Legal Affairs and Contracts and to the Sponsor, as necessary
• Keeps track of progress with contract/budget negotiation and timelines for site activation using CTMS or other tracking system
• Keeps project team informed of progress and of any potential delays
• Finalizes the site contract/budget and obtains the necessary signatures
• Informs the appropriate parties of contract execution in a timely manner
• Updates CTMS, all necessary trackers, and ensures proper filing of the contract/budget and communications

Follow Up and Close Out

• Manages the site contract / budget amendments process during the course of the trial
• Performs site budget reconciliation during the negotiation process and at study closure
• May coordinate, with Legal Affairs and Contracts, the review and negotiation of the confidentiality disclosure agreement of the interested sites
• Maintains and develops a productive and professional relationship with research sites, Sponsor and project teams
• Participates in meetings with Project Managers and / or Sponsor as required

Requirements

Education

• Bachelor's degree in a field relevant to clinical research or equivalent experience

Experience

• Minimum of 3 years of clinical research experience in the biotechnology, pharmaceutical or CRO industry, including 2 years of experience managing site budget negotiation
• Good knowledge of good clinical practice, ICH standards and applicable regulations

Knowledge and Skills

• Excellent English written and spoken skills
• Strong ability to carry out different tasks