Clinical Operations Manager

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

Job Description

Reporting to the Clinical Research Country Lead, an exciting opportunity has arisen for a Clinical Operations Manager . This position is responsible for ensuring the performance, compliance, and execution of assigned clinical trial protocols within the country, in accordance with ICH-GCP guidelines, local regulatory requirements, company policies, quality standards, and safety reporting obligations.

The role plays a critical part in supporting study start-up, regulatory submissions, financial management, and operational delivery of clinical trials. Working closely with internal stakeholders, investigators, vendors, and regulatory authorities, you will help drive study success while ensuring compliance and operational excellence.

What you will do:

• Lead and oversee country-level study start-up activities, including clinical trial submissions, approvals, ethics committee interactions, and regulatory authority communications.
• Manage local study operations, including informed consent, clinical and ancillary supplies, import/export requirements, archiving, insurance processes, and compliance documentation.
• Own country and site budget management, financial compliance, payment processes, and the development, negotiation, and execution of Clinical Trial Research Agreements (CTRAs).
• Collaborate with internal functions including Finance, Legal, Regulatory Affairs, and Pharmacovigilance, as well as external vendors, to ensure timely delivery of study milestones.
• Drive process improvements, contribute to local Standard Operating Procedures, and serve as a Subject Matter Expert for assigned operational topics.
• Support talent development through mentoring, onboarding, while contributing to strategic local initiatives and projects.

What skills you will need:

• Bachelor's Degree in Life Sciences, Business Administration, Finance, Healthcare, or a related discipline.
• Minimum 5 years of experience in clinical research or a combination of clinical research and finance/business operations.
• Strong knowledge of clinical trial regulations, ICH-GCP, local regulatory requirements, and study start-up processes.
• Proven experience in budget management, contract negotiations, and Clinical Trial Research Agreements (CTRAs).
• Solid understanding of the European Clinical Trials Regulation (EU CTR), including submission requirements and timeline, and of European Union In Vitro Diagnostic Regulation (IVDR).
• Excellent problem-solving and critical thinking skills, with the ability to identify risks, determine root causes, and implement effective solutions.
• Strong communication, stakeholder management, negotiation, conflict resolution, and cross-functional collaboration skills.
• Proficiency in clinical systems, digital technologies, and AI-enabled tools supporting clinical operations.
• Fluent written and verbal communication skills in both Portuguese and English.

Travel: Approximately 15% domestic and international travel may be required.

Why Join Us?

As a company, we keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

Required Skills:

• Adaptability
• Adaptability
• Business Management
• Clinical Development
• Clinical Information Systems
• Clinical Operations
• Clinical Research
• Clinical Site Management
• Clinical Trial Agreements (CTA)
• Clinical Trial Compliance
• Clinical Trial Documentation
• Clinical Trial Management
• Clinical Trial Planning
• Clinical Trials Monitoring
• Clinical Trials Operations
• Conceptual Thinking
• Conflict Management
• Critical Thinking
• Cross-Cultural Awareness
• Data Operations
• Good Clinical Practice (GCP)
• Healthcare Delivery Systems
• ICH GCP Guidelines
• Lateral Thinking
• Liaison Work {+ 7 more}