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Merck is seeking a Global Clinical Site Agreement (CSA) Lead to support activities within the Start-up Solution Unit Team:
* Develop CSA Strategy Plans at the study level in collaboration with internal and external partners.
* Act as the CSA delivery expert for high-priority studies and monitor CSA performance.
* Escalate and resolve issues related to clinical site budgets and agreement processes.
* Ensure the use of approved CSA templates and coordinate updates to legal documents.
* Lead the development of negotiating guidance documents, including budgets and contract terms.
* Approve Fair Market Value assessments for investigator grants.
* Manage or approve budget estimates for complex trials at various levels.
* Customize Confidentiality Agreements and coordinate escalation and feedback processes.
This position is remote with flexible location options.
Ideal candidates will have:
* At least 10 years of clinical research experience in CRO or pharmaceutical/biotech industries.
* Understanding of clinical development and study operations.
* At least 5 years of experience in contract and budget negotiation at the global or regional level.
* Experience overseeing external service providers and managing contracts related to HCP activities.
* Thorough knowledge of ICH-GCP and relevant laws and regulations.
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