Clinical Operations Manager - Finance (REMOTE)

Merck KGaA Darmstadt Germany - Santa Fe, NM

Full-time - Mid Level

Remote - Santa Fe, NM

Chemical Manufacturing

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, including preparation, negotiation, and execution of various clinical research agreements and budgets. The position requires collaboration with internal and external stakeholders to meet deliverable timelines and maintain quality standards.

Responsibilities

• Prepare, analyze, negotiate, and execute required site agreements and associated budgets including Clinical Trial Research Agreements (CTRA) and Master Clinical Trial Research Agreements (MCTRA).
• Utilize legal fallback language and escalate site-specific issues that do not comply with established guidelines.
• Maintain database and files for all contracts, approvals, and budgets.
• Perform quality control checks of agreements prior to execution.
• Coordinate with CRM, CTC, CRA, and COM-R to collaborate on Site Ready Deliverables.
• Lead and develop relationships with key investigational sites and Site Management Organizations.
• Contribute to the development of local SOPs.
• Review, negotiate, and facilitate business approval for Site Access Forms and EMR Access Forms.
• Liaison with Payment Coordinators to issue contingency approvals and amend Agreements as required.
• Contribute or lead initiatives and projects adding value to the business.
• Act as a Subject Matter Expert (SME) and mentor for the COM team.
• Influence investigators and external partners to deliver clinical and financial contracts.
• Work in partnership with various internal and external teams.

Requirements

• Bachelor's Degree and 3 years of experience in negotiating Contracts or Budgets.
• Strong knowledge of budget and contract negotiations and local regulatory environment.
• Excellent verbal and written communication skills in local language and English.
• Strong coordination and organizational skills.
• Ability to indirectly influence stakeholders and resolve issues with minimal oversight.

Nice-to-haves

• Juris Doctor (JD) degree preferred.