Remote Clinical Trial Contracts & Budget Lead

Merck; Lansing (MI); Remote; USD 90,000 - 130,000; Full time

Job summary

Merck in the United States is seeking a role accountable for performance and compliance for assigned clinical contracts in line with ICH/GCP and country regulations, under supervision of Sr. COM, Head COMs or Therapy Area Heads.

The person will prepare, analyze, negotiate, and revise clinical research contracts and budgets through all phases of the contract cycle. Key duties include preparing site agreements and budgets (CTRA, CDA, MFS, FUA), maintaining contract records, coordinating with

Qualifications

• Bachelor's Degree or higher
• 3+ years of experience in negotiating contracts or budgets
• Juris Doctor (JD) degree (preferred)

Responsibilities

• Prepare, analyze, negotiate, and execute required site agreements and associated budgets including CT RAs, MCTRA, CDAs, MCDA, IRAG, MFS, FUA, Amendments and Assignments
• Utilize legal fallback language and budget parameters and escalate non-compliant issues for review
• Maintain database and files for all contracts, approvals, and budgets
• Oversee document and metric tracking to ensure timely execution of site agreements
• Perform quality control checks of agreements prior to execution
• Collaborate with CRM/CTC/CRA/COM-R to deliver Site Ready deliverables and mitigate risks
• Lead relationships with investigational sites and Site Management Organizations
• Contribute to SOP development
• Review and expedite Site Access Forms and EMR access policies
• Coordinate with Finance for contingency approvals and amendments
• Lead or contribute to value-adding initiatives and projects
• Share process SME knowledge within COM and country operations
• Influence investigators and partners to meet contracts within fair market value
• Collaborate with GCTO, regulatory affairs, pharmacovigilance, HQ and external vendors/sites

Skills

Budget negotiation

Contract negotiation

Leadership

Influencing skills

Project management

Problem solving

Quality control

Regulatory compliance

Clinical operations

GCP knowledge

Education

Bachelor's degree or higher

Juris Doctor (JD) preferred

Job description

Merck in the United States is seeking a role accountable for performance and compliance for assigned clinical contracts in line with ICH/GCP and country regulations, under supervision of Sr. COM, Head COMs or Therapy Area Heads.

The person will prepare, analyze, negotiate, and revise clinical research contracts and budgets through all phases of the contract cycle. Key duties include preparing site agreements and budgets (CTRA, CDA, MFS, FUA), maintaining contract records, coordinating with