Clinical Research Operations Lead
hace 4 semanas
Key Responsibilities:
As a Clinical Research Operations Lead, you will be responsible for overseeing the performance and compliance of assigned protocols in a country, ensuring adherence to ICH/GCP and country regulations, client policies, and quality standards.
Key Deliverables:
- 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 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 for assigned protocols
- Manages country deliverables, timelines, and results for assigned protocols to meet country commitments
- Responsible for quality and compliance in assigned protocols in the country
- Contributes to the development of local SOPs
Collaboration and Communication:
Collaborates closely with Headquarters to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
Requirements:
Requires strong leadership and communication skills, with the ability to influence investigators, external partners, and country operations to adhere to budget targets and agreed payment timelines.
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