Job Description:
Our client is seeking a skilled clinical contracts associate to assist with the preparation, negotiation, changes & amendments, etc. of clinical contracts and associated documents. The team is responsible for various types clinical studies (primarily medical device) through the EMEA region and have multiple upcoming and ongoing studies that require additional support. The candidate will need to have at least 3-5 years of clinical study operations related experience (CRA, clinical study manager, clinical contracts associate, etc.), ability to work in high-paced environment and have a service-minded approach to dealing with sites with complex demands.
Responsibilities:
- Adapt study site budge template to country and site specific requirements
- Creates, prepares, reviews and edits contracts, new work orders, amendments, modifications and change orders of varying complexity and contract risk type.
- Analyzes documents to determine risk; prepares and provide alternative approaches to mitigate risk.
- Negotiates with research sites in compliance with company policies and applicable regulations.
- Works with legal, compliance, clinical quality and other stakeholders on contract language (indemnification, subject injury language, IP rights, confidentiality, compensation, etc.)
- Negotiates directly with research sites and ensures that the clinical trial budgets are in accordance with the clinical protocol requirements and associated policies.
- Reviews and approves country/site specific change of ICF concerning injury, data privacy and compensation language involving specialists from other departments.
EU: Clinical Contract Associate EMEA (237449)
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