Clinical Operations Manager - Finance (REMOTE)

Merck KGaA Darmstadt Germany - Providence, RI

Full-time - Mid Level

Remote - Providence, RI

Chemical Manufacturing

About the position

The Clinical Operations Manager - Finance is responsible for overseeing performance and compliance for clinical research protocols, ensuring adherence to ICH/GCP and local regulations. This role involves managing the contract lifecycle, including preparation, negotiation, and execution of various clinical research agreements and budgets. The position requires collaboration with internal and external stakeholders to ensure timely execution of agreements and to mitigate risks associated with clinical trials.

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 various teams to collaborate on Site Ready Deliverables and implement mitigation plans.
• Lead and develop relationships with key investigational sites and Site Management Organizations.
• Contribute to the development of local SOPs and review necessary forms for business approval.
• 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 stakeholders.

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 organizational and coordination skills.
• Ability to make independent decisions with limited oversight.

Nice-to-haves

• Juris Doctor (JD) degree preferred.

Benefits

• Health insurance
• Dental insurance
• 401k plan
• Paid holidays
• Flexible scheduling