Description
The Site Budget and Contract Lead (SBCL) 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 and Sponsors. The SBCS will be responsible for all project activities related to contracts/budgets and will interact with clients, as needed. Frequent collaboration with internal and external 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).
- You are comfortable working under time pressure and tight timeliness
More specifically, the Site Budget and Contract Lead must:
- Develop and maintain positive and productive relationships with clinical research sites and Sponsors.
- 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.
- Develop the project-specific Clinical Trial Agreement (CTA) template for studies, customized per country-specific and sponsor requirements.
- 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 amendments during 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 using an intermediary party (i.e., contractor, sub-CRO or CRA)
- Provide oversight to contractors and Sub-CROs, as well as Innovaderm SBCS across multiple countries on contracting activities, as required.
- Act as functional lead for the contract management piece in global studies as required, acting as main POC of the sponsor regarding contract management matters.
- 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 in Europe, aid, 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 with mentoring activities to junior team members.
- 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.
Requirements
Education
- Bachelor's degree in a field relevant to clinical research or equivalent experience.
Experience
- Minimum of 7 years’ experience in clinical research in site budget/contract negotiation in the biotechnology, pharmaceutical, or CRO industry, including significant and relevant experience in site selection, study start-up activities and/or has worked closely with sites or worked in a site environment.
- Minimum 2 years’ experience in a similar contract lead role in the biotechnology, pharmaceutical, or CRO industry
Knowledge and skills
- Excellent English written and spoken skills. Bilingual with Spanish, German or Polish languages. Being fluent in 2+ EU 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.
- Excellent knowledge of the Microsoft Office suite (i.e., Word, Excel, PowerPoint, Outlook).
- Prior clinical research experience in EU countries, and knowledge of local regulations and processes is an asset
- Experience of dermatological and rheumatological clinical research is an asset
- Ability to work under pressure and with tight timelines is essential.
- Quick learner, good adaptability and versatile
- Ability to work in a team environment and establish good relationships with colleagues, sponsors, and sites.
- Organized, able to juggle competing priorities, and work in a fast pace and evolving environment.
- Flexibility, positive attitude, superior attention to detail, and critical thinking 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).
About Indero
Indero is a contract research organization (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.
Description de poste
Profil recherché
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