Merck KGaA Darmstadt Germany - Springfield, IL

posted 7 days ago

Full-time - Mid Level
Onsite - Springfield, IL
Chemical Manufacturing

About the position

The Clinical Operations Manager - Finance at Merck is responsible for ensuring performance and compliance for assigned clinical research protocols in accordance with ICH/GCP and local regulations. This role involves preparing, analyzing, negotiating, and revising clinical research contracts and budgets throughout the contract cycle, while collaborating with various internal and external stakeholders to meet deliverable timelines and commitments.

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 in conformity with naming conventions.
  • Assume responsibility for 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, and COM-R 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, negotiate, and facilitate business approval for necessary 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 within the COM team.

Requirements

  • Bachelor's Degree and 3 years of experience in negotiating Contracts or Budgets.
  • Strong understanding of local regulatory environment and submission processes.
  • Excellent verbal and written communication skills in local language and English.
  • Strong coordination and organizational skills.
  • Ability to influence investigators and external partners.

Nice-to-haves

  • Juris Doctor (JD) degree.

Benefits

  • Bonus eligibility
  • Long term incentive if applicable
  • Health care and other insurance benefits for employee and family
  • Retirement benefits
  • Paid holidays
  • Vacation
  • Sick days
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