Remote Clinical Contracts & Site Operations Lead

MSD; Rahway (NJ); Remote; USD 117,000 - 184,000; Full time

Job summary

MSD is seeking a Senior role focused on performance and compliance for assigned clinical trial contracts and budgets, ensuring adherence to ICH/GCP and country regulations. You will oversee all phases of the contract cycle, including site agreements, amendments, and MDFs, with a collaborative, governance-driven approach.

Your responsibilities include leading negotiations, ensuring timely execution, and mentoring regional teams while ensuring budgets align with FMV and strategic objectives.

Qualifications

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

Responsibilities

• Prepare, analyze, negotiate, and execute site agreements and budgets (CTRA, MCTRA, CDA, MCDA, IRAG, MFS, FUA, etc.).
• Use budget parameters and escalate non-compliant issues for review.
• Maintain contracts, approvals, and budgets database with standardized naming and storage conventions.
• Oversee document and metric tracking to ensure timely site agreement execution.
• Perform quality control checks of agreements prior to execution.
• Collaborate with CRM/CTC/CRA/COM-R and finance to deliver Site Ready deliverables and mitigate risks.
• Lead relationships with investigational sites and Site Management Organizations across contracting/budgeting interfaces.
• Contribute to SOP development and review Site Access/EMR policies as required.
• Coordinate with CTC-Fs on contingency approvals and amendment of agreements.
• Drive process improvements and share best practices within the COM team.
• Mentor/coach team members and support knowledge transfer across country operations.
• Influence investigators and external partners to deliver contracts within fair market value.
• Collaborate with internal and external stakeholders including HQ to meet country timelines.

Skills

Clinical Site Management

Clinical Trial Compliance

Clinical Trial Management

Clinical Trials Operations

ICH GCP Guidelines

Influencing Skills

Leadership

Negotiation

Problem Solving

Project Management

Quality Control Management

Regulatory Compliance

Education

Bachelor's Degree or higher

Juris Doctor (JD) degree preferred

Job description

MSD is seeking a Senior role focused on performance and compliance for assigned clinical trial contracts and budgets, ensuring adherence to ICH/GCP and country regulations. You will oversee all phases of the contract cycle, including site agreements, amendments, and MDFs, with a collaborative, governance-driven approach.

Your responsibilities include leading negotiations, ensuring timely execution, and mentoring regional teams while ensuring budgets align with FMV and strategic objectives.