Country Clinical Operations Lead - Start-up & Compliance

Merck; Oeiras; On-site; EUR 60,000 - 90,000; Full time

Job summary

Merck in Portugal is seeking a Clinical Operations Manager to oversee country-level trial execution, regulatory submissions, and budget control. You will coordinate with Finance, Legal, Regulatory Affairs, and external vendors to ensure compliant delivery of study milestones and start-up activities.

A cross-functional leader with strong communication in Portuguese and English is essential. The role emphasizes process improvements, SOPs, and talent development while traveling up to 15%

Qualifications

• Minimum 5 years of experience in clinical research or related operations.
• Strong knowledge of ICH-GCP and local regulatory requirements.
• Experience with CTRAs and budget management.
• Fluent Portuguese and English communication.

Responsibilities

• Lead country-level study start-up activities and regulatory submissions.
• Oversee local study operations, supplies, archiving, and contract execution.
• Manage country budget, CTRAs, and payments.
• Collaborate with Finance, Legal, Regulatory, and external vendors.
• Drive process improvements and SOP development.

Skills

Clinical Operations

Budget Management

CTRAs

ICH GCP

Regulatory Compliance

Cross-Functional Collaboration

Portuguese & English

Vendor Management

Education

Bachelor's Degree in Life Sciences, Business Administration, Finance, Healthcare, or related discipline

Tools

Clinical Information Systems

AI-enabled Tools

Job description

Merck in Portugal is seeking a Clinical Operations Manager to oversee country-level trial execution, regulatory submissions, and budget control. You will coordinate with Finance, Legal, Regulatory Affairs, and external vendors to ensure compliant delivery of study milestones and start-up activities.

A cross-functional leader with strong communication in Portuguese and English is essential. The role emphasizes process improvements, SOPs, and talent development while traveling up to 15%