The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. Ability to indirectly influence investigators, vendors, external partners and country managers to deliver these commitments is a must. This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country based regulations, laws and procedures with minimal support from the client management. The position requires skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment, submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.
The position requires the ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
On the Client level:
FINANCIAL (as applicable):
- Assistance with the ownership of country and site budgets.
- Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
- Oversight and tracking of clinical research-related payments
- Payment reconciliation at study close-out.
COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS (as applicable):
- Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
- Development of local language materials including local language Informed Consents and translations.
- Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.
MANAGEMENT & QUALITY OVERSIGHT:
- Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments.
- Contributes to the development of local SOPs.
- Works in close collaboration internally with Clinical country operations (CRD, CRM,CTC,CRA), Country Quality Manager (CQM), Finance, Medical Affairs, Regulatory Affairs, PharmacoVigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
LOCAL PROCESS OVERSIGHT: (as applicable):
- Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
- Enters and updates country information in clinical, regulatory, safety and finance systems.