Clinical Operations Manager

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From MSD’s original posting

Job Description Clinical Operations Manager Brief Description of Position This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, internal policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready. Responsibilities include, but are not limited to: • Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). • Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with Sr.COM /other roles. • Executes and oversees clinical trial country submissions and approvals for assigned protocols. • Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority…