Site Budget and Contract Specialist
About The Position
The Site Budget and Contract Specialist (SBCS) leads the development of investigator budget and contract proposals. The 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 SBCS will be responsible for all project activities related to contracts/budgets and will be client facing. Frequent collaboration with internal teams is expected.
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).
More specifically, the Site Budget and Contract Specialist must:
- Develop and maintain positive and productive relationships with clinical research sites
- Develop the draft clinical budgets for new studies
- Develop and maintain the country-specific minimum and maximum budget grid for negotiation with sites
- 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
- Facilitate the negotiation and signature of the site budgets/contracts with investigators, in collaboration with Legal Affairs, and when appropriate with Sponsors
- 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
- Bachelor's degree in a field relevant to clinical research or equivalent experience.
- Minimum of 3 years’ experience in clinical research in the biotechnology, pharmaceutical, or CRO industry, including significant and relevant experience in site selection, study start-up activities, site budget/contract negotiation and/or has worked closely with sites or worked in a site environment
Knowledge and skills
- Excellent English written and spoken skills. Bilingual with French or Polish languages 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).
- Prior clinical research experience in EU and Asian countries, and knowledge of local regulations and processes is an asset
- Strong interpersonal skills.
The work environment
At Innovaderm, 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
- Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
- Ongoing learning and development
The successful candidate for this position is given to work remotely anywhere in Poland.
Employees located outside of North America are expected to have some flexibility in their working hours to accommodate team or client meetings as needed. All efforts will be made by Innovaderm to accommodate various time zones of team members.
Covid-19 vaccination policy: The health and safety of all is important to us. In accordance with the applicable vaccination policy, Innovaderm demands that all employees present at its offices as well as all client and vendor sites (including clinical sites) be adequately vaccinated, under reserve of exemptions related to adaptation requirements prescribed by law.
Innovaderm is a contract research organization (CRO) specialized in dermatology. 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, Innovaderm continues to grow and expand in North America and Europe.
Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Innovaderm only accepts applicants who can legally work in Poland.