Description
We are seeking a Clinical Operations Manager - Regulatory to oversee performance and compliance for assigned protocols in Greece. The successful candidate will be responsible for budget and finance aspects, execution and oversight of clinical trial country submissions and approvals, and ensuring Site Ready.
Responsibilities include:
- Managing country and site budgets
- Developing, negotiating and completing Clinical Trial Research Agreements (CTRAs)
- Overseeing and tracking clinical research-related payments
- Executing and overseeing clinical trial country submissions and approvals
- Developing local language materials, including informed consents and translations
- Managing country deliverables, timelines and results for assigned protocols
- Contributing to the development of local SOPs
- Coordinating and liaising with Project Managers, CTAs, CRAs and others to ensure country deliverables are met
- Providing support and oversight to local vendors
- Overseeing and coordinating local processes, including clinical and ancillary supplies management, importing and exporting requirements, and insurance process management
- Entering and updating country information in clinical and finance systems
- Ensuring local regulatory and financial compliance
The ideal candidate will have a significant impact on delivering country-specific trial commitments and objectives, particularly during study start-up. They will be able to influence investigators, external partners and country operations, and adhere to budget targets and agreed payment timelines.