Clinical Operations Manager - Finance (REMOTE)

About the position

The Clinical Operations Manager - Finance at Merck is responsible for ensuring performance and compliance for clinical research protocols in accordance with ICH/GCP and local regulations. This role involves managing the entire contract cycle for clinical research agreements, including preparation, analysis, negotiation, and execution of various agreements and budgets. The position requires collaboration with multiple stakeholders to ensure timely execution and adherence to quality standards.

Responsibilities

• Prepare, analyze, negotiate, and execute required site agreements and associated budgets including Clinical Trial Research Agreements (CTRA), Master Clinical Trial Research Agreements (MCTRA), Confidentiality Disclosure Agreements (CDA), and others.
• Utilize legal fallback language, budget parameters, and escalate 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 (Finance and legal if appropriate) to collaborate on Site Ready Deliverables.
• Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface.
• Contribute to the development of local SOPs.
• Review, negotiate, escalate, and facilitate business approval for Site Access Forms, EMR Access Forms, and Institution Policies as required.
• Liaison with Payment Coordinators/CTC-Fs to issue contingency approvals, troubleshoot, and amend Agreements as required.
• Contribute or lead initiatives and projects adding value to the business, as appropriate/required.
• Act as a process Subject Matter Expert (SME), sharing best practices with the COM team and other Country Operations roles.

Requirements

• Experience in clinical operations and contract management within the pharmaceutical or clinical research industry.
• Strong negotiation skills and experience with clinical trial agreements and budgets.
• Knowledge of ICH/GCP guidelines and local regulations related to clinical research.
• Excellent organizational skills and attention to detail for document tracking and quality control.
• Ability to collaborate effectively with cross-functional teams and external stakeholders.

Nice-to-haves

• Experience with database management for contracts and budgets.
• Familiarity with site management organizations and investigational sites.
• Project management experience in clinical operations.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Paid holidays and vacation time
• Professional development opportunities
• Flexible scheduling options