Clinical Operations Manager- Finance

Primary Responsibilities:Manages country deliverables, timelines, and results for assigned protocols to meet country commitments including quality and compliance in assigned protocols in country.Has ownership of local regulatory and financial compliance.Contributes to the development of local SOPs.Oversees CTCs as applicable.Coordinates and liaises with Clinical Research Managers (CRMs), Clinical Research Associates (CRAs) and Clinical Trial Coordinators (CTCs), Finance and Legal if appropriate to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements (CTRAs) and local milestones.Collaborates closely with Headquarter 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, import and export 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.Delivers clinical and financial contracts within fair market value through continual interaction with local clinical teams.Contributes or leads initiatives and projects adding value to the businessHas ownership of country and site budgets including development, negotiation, and completion of Clinical Trial Research Agreements (CTRA).Oversees and tracks clinical research‐related payments and payment reconciliation at study close‐out.Oversees Foreign Corrupt Practices Act (FCPA), Denied Party Screening/Office of Foreign Assets Control (DPS/OFAC) and maintenance of financial systems and financial forecasting in conjunction with SCOM, CRD and other roles.Influences investigators, external partners, and country operations to adhere to budget targets and agreed payment timelines.

Education and Certification:Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.

Skills and Experience:5‐7 years clinical research or combined experience in Clinical Research and Finance/Business.Expertise of core clinical systems, tools, and metrics.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 start-up.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 a strong understanding of local regulatory environment.Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.

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