Job Description - Site Budget and Contract Specialist (Spain)
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
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.
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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