Offer summary

Qualifications:

Bachelor's degree in a relevant field or equivalent experience., Minimum of 3 years of clinical research experience, including 2 years in site budget negotiation., Good knowledge of clinical practices, ICH standards, and applicable regulations., Excellent English communication skills and proficiency in Microsoft Office suite..

Key responsabilities:

Prepare and negotiate contracts and budgets for clinical trial agreements with investigator sites.

Manage budget negotiations to ensure compliance with Sponsor-approved limits.

Track progress of contract and budget negotiations and keep project teams informed.

Finalize contracts and budgets, ensuring timely execution and proper documentation.

Job description

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

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:

Permanent full-time position
Flexible schedule
Vacation
Home-based position
Ongoing learning and development

About Indero

A Global Clinical Leader In Dermatology!

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.

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.

Required profile