Job Description

The Senior Site Budget and Contract Specialist (Sr SBCS) leads the development of investigator budget and contract proposals. The Sr SBCS acts as the main point of contact for budget and contract negotiations for investigator sites across North America, EU and other countries, as applicable. The Sr SBCS will be responsible for all project activities related to contracts/budgets and will interact with clients, as needed. Frequent collaboration with internal teams is expected. Mentoring of more SBCS and other team members in the contracts/budgets related field.

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

• Develop and maintain positive and productive relationships with clinical research sites and clients
• Develop the draft clinical budgets for new studies
• Develop and maintain the country-specific, sponsor approved, minimum and maximum budget grid for negotiation with sites (more complex studies)
• Obtain the approved Clinical Trial Agreement (CTA) template to be used for the study from Legal Affairs
• Develop the project-specific Clinical Trial Agreement (CTA) template for studies, customized per country-specific requirements on a global scale
• Facilitate the negotiation and signature of the site budgets/contracts with investigators, in collaboration with Legal Affairs, and when appropriate with Sponsors. Adapt processes per country-specific requirements.
• Manage contract/budget negotiations in countries outside of main region (EU-NA), if possible
• Manage contract/budget amendments during the course of the trial
• Update appropriate tracking systems to facilitate site payments
• Regularly attend internal and client project team meetings, as necessary
• Collaborate with internal teams as needed (i.e., Project Management, Regulatory Affairs, Legal Affairs, Finance, CTMS team, etc.)
• Strategize to ensure deliverables for fully executed contracts are made on time, according to study timelines
• Review and provide support to Regulatory Affairs on informed consent form (master template) to ensure subject compensation text is aligned with approved study budget
• Depending on location and language of study sites, facilitate site negotiations and communications through the use of an intermediary party (i.e., sub-CRO or CRA)
• Provide oversight to Sub-CROs on contracting activities, as required
• Make all efforts to ensure total study budget is respected and within scope, across all sites. Escalates to sponsor for out-of-scope budget requests, as needed
• For employees located outside of North America, provide assistance, as needed, to communicate with sites in local language, if possible
• Maintain adequate training and compliance with internal processes and SOPs
• Participate in internal departmental projects initiated by the site selection and contracting group
• Participate in internal departmental projects initiated by other groups to provide insight on site budget and contracting activities as needed
• Act as subject matter expert on budget and contract negotiations guiding project teams as needed
• Support the Manager, Site Selection and Contracting to ensure knowledge of the goals, scope and requirements of the internal and external projects and to ensure high quality results are delivered
• Mentor and assist in onboarding of new team members as well as provide trainings to the team on the specific processes related to contracts and budgets

Requirements

Education 

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

Experience 

• Minimum of 5 years’ experience in site budget/contract negotiation in clinical research in the biotechnology, pharmaceutical, or CRO industry, including significant and relevant experience in study start-up activities and/or has worked closely with sites or worked in a site environment
• Prior clinical research experience in EU and Asian countries, and knowledge of local regulations and processes is an asset
• Experience of dermatological clinical research is an asset

Knowledge and skills

• Excellent English written and spoken skills. Bilingual with French or other European language is an asset.
• 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:

• Permanent full-time position
• Vacation, PPK, health allowance
• Home-based position with teleworking allowance
• Ongoing learning and development

Work location

This position is opened to candidates across Poland (home-based position).

Recruitment process: what to expect

• As part of the recruitment process for this position you will meet various team members at Indero
• The first interview will be conducted by phone (20 minutes) and the second via video conference (1 hour)
• The second interview includes a short presentation for which reasonable advance preparation is required (preparation is not timed and can be completed over a few days). You may think of it as one interview question for which you have the opportunity to develop a strong structured response that goes beyond the surface.

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 Poland.

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Notre entreprise

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