Job Description

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.

This role will be perfect for you if

• 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

IDEAL PROFILE

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 projects simultaneously, to organize their work effectively, and to work under pressure in accordance with deadlines.
• Good judgment and problem-solving skills.
• Excellent knowledge of the Microsoft Office suite (i.e., Word, Excel, PowerPoint, Outlook).
• Experience in customer service is an asset
• Strong interpersonal skills.

Our company

The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

• Flexible work schedule
• Permanent full-time position
• Company benefits package
• Ongoing learning and development

About Indero

Indero is a CRO specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Spain.

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