Clinical Operations Lead — Budgets, Submissions & Compliance

Merck Gruppe - MSD Sharp & Dohme; Argentina; Remote; ARS 1,200,000 - 1,800,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme in Argentina seeks an experienced professional to oversee country budgets, CTRA development, and submissions for clinical trials. You will manage payments, financial forecasting, and ensure compliance across country operations, liaising with IRB/Regulatory Authorities and HQ to align timelines.

The role requires strong budgeting, negotiation, and regulatory experience, with collaboration across GCTO country operations, finance, and external partners.

Qualifications

• 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business.
• Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.
• Strong understanding of ICH GCP Guidelines and regulatory environments.

Responsibilities

• Owns country budgets and development/ negotiation of Clinical Trial Research Agreements (CTRA).
• Oversees clinical research payments, payment reconciliation, and financial forecasting with senior staff.
• Executes and oversees country submissions and approvals for assigned protocols.
• Develops local language materials including Informed Consents and translations; interacts with IRB/IEC and Regulatory Authority.
• Manages country deliverables, timelines and results to meet commitments; ensures quality and compliance.
• Co-ordinates with CRM/CTC/CRA/Finance/Legal to ensure country milestones, budgets, CTRAs and local milestones are achieved.

Education

Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience

Job description

Merck Gruppe - MSD Sharp & Dohme in Argentina seeks an experienced professional to oversee country budgets, CTRA development, and submissions for clinical trials. You will manage payments, financial forecasting, and ensure compliance across country operations, liaising with IRB/Regulatory Authorities and HQ to align timelines.

The role requires strong budgeting, negotiation, and regulatory experience, with collaboration across GCTO country operations, finance, and external partners.