Clinical Operations Manager

About the role

Merck Sharp & Dohme (MSD) is hiring a Clinical Operations Manager in Argentina. The role is accountable for performance and compliance of assigned protocols in line with ICH/GCP, country regulations, company policies, quality standards and adverse event reporting requirements. It reports to the line manager and covers budget and finance, country submissions and approvals, and ensuring sites are ready.

Key responsibilities

• Own country and site budgets, negotiate and complete Clinical Trial Research Agreements (CTRA), track payments and reconcile them at study closeout.
• Oversee FCPA, DPS/OFAC compliance and maintain financial systems, with financial forecasting with senior colleagues.
• Execute and oversee country submissions and approvals, develop local informed consents and translations, and liaise with IRB/IEC and the regulatory authority.
• Manage country deliverables, timelines and quality/compliance, contribute to local SOPs and oversee CTCs.
• Coordinate with CRM, CTC, CRA, finance and legal, and collaborate with headquarters to align country timelines.
• Support local vendors, manage clinical and ancillary supplies, import/export, destruction, filing, archiving, retention and insurance, and enter country data in clinical and finance systems.
• Influence investigators, partners and country operations, and act as subject matter expert and mentor to the COM team.

Required profile

• 5 years of experience in clinical research, or combined experience in clinical research and finance/business.
• Bachelor's degree in Business, Finance, Administration, Life Sciences or equivalent; healthcare-related experience preferred.
• Ability to work independently, make decisions with limited oversight, and lead a team of CTCs where applicable.

Required skills

• Core clinical systems, tools and metrics, and knowledge of ICH GCP guidelines.
• Budget and contract negotiation, local regulatory environment and submission/approval processes.
• Strong coordination, problem-solving, time management and negotiation skills, in local language and English.