Senior Clinical Operations & Contracts Lead

Merck; Juneau (AK); Remote; USD 117,000 - 184,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision coverage

Paid holidays

Vacation and sick leave

Job summary

Merck in Rahway, NJ is seeking a seasoned Contract Specialist to ensure performance and regulatory compliance for assigned clinical trial protocols. You will prepare, analyze, and negotiate clinical research contracts and budgets across all cycle stages, coordinating with clinical and regulatory teams to meet country timelines.

You will manage site agreements, budgets, and related documents, applying SOPs and best practices, while liaising with vendors and sites to optimize outcomes and value.

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 site agreements and budgets including CTAs, MTAs, CDAs, MCAs, IRAG, MFS, FUA, reimbursement letters, amendments and assignments.
• Utilize legal fallback language and budget parameters; elevate non-compliant site issues for review.
• Maintain database/files for contracts, approvals, budgets with uniform naming and saving conventions.
• Own all aspects of document and metric tracking to ensure timely execution of site agreements.
• Perform quality control checks of agreements prior to execution.
• Coordinate with CRM, CTC, CRA, COM-R, and others to deliver Site Ready Deliverables; identify risks and implement mitigations.
• Lead and develop relationships with investigational sites and SMOs across contracting and budgeting interface.
• Contribute to development of local SOPs.
• Review, negotiate, escalate, and obtain approvals for Site Access Forms, EMR Access Forms, and Institution Policies.
• Liaise with CTC-Fs to issue contingency approvals, troubleshoot, and amend agreements as needed.
• Contribute or lead initiatives adding value to the business; support COM/team knowledge transfer.

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

Merck in Rahway, NJ is seeking a seasoned Contract Specialist to ensure performance and regulatory compliance for assigned clinical trial protocols. You will prepare, analyze, and negotiate clinical research contracts and budgets across all cycle stages, coordinating with clinical and regulatory teams to meet country timelines.

You will manage site agreements, budgets, and related documents, applying SOPs and best practices, while liaising with vendors and sites to optimize outcomes and value.