Remote Clinical Contracts & Site Ops Lead

Merck; Honolulu (HI); Remote; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation

Job summary

Merck is seeking a Contract & Budget Specialist to oversee performance and compliance for site contracts, budgets, and related documentation across countries in alignment with ICH GCP and regulations. You'll prepare, analyze, and negotiate contracts through all cycle phases with internal teams and external partners.

You will coordinate with CRM, CTC, CRA, and finance to ensure timely site deliverables, maintain rigorous records, and support SOP development.

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, MCTRAs, CDAs, MC DAs, IRAG, MFS, FUA, Reimbursement Letters, Amendments and Assignments.
• Utilize legal fallback language, budget parameters, and elevate site-specific issues that do not comply with established guidelines for review and approval
• Maintain database and files for all contracts, approvals, and budgets in conformity with uniform naming and savings convention
• Assume responsibility for all aspects of document and metric tracking to ensure timely execution of site agreements
• Perform quality control checks of agreements prior to execution
• Coordinate and liaise with CRM, CTC, CRA, COM-R to collaborate on Site Ready Deliverables including risks and mitigation plans
• Lead and develop relationships with key investigational sites and SMOs across contracting and budgeting interface
• Contribute to the development of local SOPs
• Review, negotiate, escalation, and facilitate business approval for Site Access Forms, EMR Access Forms, and Institution Policies
• Liaison with Payment Coordinators / CTC-Fs to issue contingency approvals, troubleshoot, and amend Agreements
• Contribute or lead initiatives adding value to the business
• Contribute to COM team knowledge by acting as SME, sharing best practices, providing training
• Act as buddy/mentor sharing best practices
• Influence investigators, external partners and country operations to deliver contracts within fair market value
• Work in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and HQ; externally with vendors and sites

Skills

Clinical Site Mgmt

Clinical Trial Compliance

Clinical Trial Management

Clinical Trials Operations

ICH GCP

Influencing

Leadership

Negotiation

Problem Solving

Project Management

Quality Control

Regulatory Compliance

Education

Bachelor's Degree or higher

3+ years negotiating contracts or budgets

Juris Doctor (JD) degree (preferred)

Job description

Merck is seeking a Contract & Budget Specialist to oversee performance and compliance for site contracts, budgets, and related documentation across countries in alignment with ICH GCP and regulations. You'll prepare, analyze, and negotiate contracts through all cycle phases with internal teams and external partners.

You will coordinate with CRM, CTC, CRA, and finance to ensure timely site deliverables, maintain rigorous records, and support SOP development.