.As a Start Up Lead, you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.Under the oversight of the Senior Start Up Lead, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals, and to ensure Site Ready.What You Will Be DoingOwnership 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 country.Contributes to the development of local SOPs. Oversees CTAs as applicable.Coordinates and liaises with CTM, CTA, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs, and local milestones. Collaborates closely with Headquarters to align country timelines for assigned protocols.Provides support and oversight to local vendors as applicable.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.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 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
