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Contract and Budget Negotiator Specialist in Brazil
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The Site Activation Specialist will work with sites from North America. The Specialist prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines.
Key Responsibilities- With moderate oversight and supervision, serve as a Single Point of Contact (SPOC) to perform feasibility, site activation, and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs, and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency, and accuracy, under guidance of senior staff.
- Prepare site documents, reviewing for completeness and accuracy.
- Inform team members of completion of regulatory contractual and other documents for individual sites.
- Distribute completed documents to sites and internal project team members.
- Update and maintain internal systems, databases, tracking tools, timelines, and project plans with accurate and complete project-specific information.
- Review, track, and follow up on the progress, approval, and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.
- Bachelor's Degree in Life Sciences or a related field.
- 3 years' experience in a healthcare environment or equivalent combination of education, training, and experience.
- Coming from a CRO or pharma company is ideal.
- Previous experience in contract and budget negotiation is mandatory. It's valuable to have experience working with Clinical Trial Agreements.
- Advanced level of English.