In this role you are accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, clients policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, you would be responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.
Essential Job Duties
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 SCOM /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 country.
Contributes to the development of local SOPs. Oversees CTCs as applicable.
Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
Collaborates closely with Headquarter to align country timelines for assigned protocols.
Provides support and oversight to local vendors as applicable.
Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
Required to in/directly influence investigators, external partners and country operations to adhere to partners and country operations to adhere to budget targets and agreed payment timelines.
Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related-interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
Oversees and coordinates local processes, 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 and finance systems.
Requirements: 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business Education/Qualifications/Certifications and Licenses
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
Expertise of core clinical systems, tools and metrics o Excellent English skills
Strong coordination and organizational skills
Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study startups
Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the SCOM or manager.
Ability to make decisions independently with limited oversight from SCOM or manager.
Requires strong understanding of local regulatory environment
Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
This position is open to all candidates.