Site Budget and Contract Specialist
PolandFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- Excellent English written and spoken skills.
- 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
- Required Skills
- Microsoft ExcelMicrosoft OfficePowerPoint
Requirements
- Bachelor's degree in a field relevant to clinical research or equivalent experience.
- Minimum of 3 years of clinical research experience in the biotechnology, pharmaceutical or CRO industry
- 2 years of experience managing site budget negotiation
- Good knowledge of good clinical practice, ICH standards and applicable regulations
- 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.
Responsibilities
- Obtains the minimum and maximum site budget prepared by Business Development and approved by the Sponsor.
- Prepares the contract schedule (study information, timelines and payment information) in collaboration with the Project Manager.
- 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
- Finalizes the site contract/budget and obtains the necessary signatures
- Updates CTMS, all necessary trackers, and ensures proper filing of the contract/budget and communications
- 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
- Maintains and develops a productive and professional relationship with research sites, Sponsor and project teams
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