COSS-0, Associate Director, SSUL, Clinical Site Agreements

Merck Group; London; Remote; GBP 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company is seeking a Global Clinical Site Agreement (CSA) Lead to develop CSA Strategy Plans and manage budgets and agreements. This remote position demands 10+ years of clinical research experience and expertise in contract negotiation. The ideal candidate will have strong knowledge of ICH-GCP and relevant regulations, ensuring compliance and efficiency in clinical operations.

Qualifications

• 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.

Responsibilities

• Develop CSA Strategy Plans at the study level in collaboration with partners.
• Act as CSA delivery expert for high-priority studies and monitor CSA performance.
• Escalate and resolve issues related to budgets and agreement processes.
• Ensure use of approved CSA templates and coordinate legal document updates.
• Lead development of negotiating guidance documents.

Skills

Clinical research experience

Contract negotiation

Budget management

Knowledge of ICH-GCP

Job description

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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.