Clinical Operations Manager

Merck Gruppe - MSD Sharp & Dohme; Lisboa; Hybrid; EUR 70,000 - 100,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme in Portugal is seeking an Clinical Operations Manager to oversee country-level trial start-up, operations, and budgeting, ensuring regulatory compliance and efficient execution of clinical protocols. You will coordinate with Finance, Legal, Regulatory Affairs and vendors to deliver milestones.

The role requires 5+ years in clinical research, strong ICH-GCP knowledge, and fluent Portuguese and English. Travel ~15% domestically and internationally.

Qualifications

• Bachelor's degree in Life Sciences, Business Administration, Finance, Healthcare or related field.
• Minimum 5 years in clinical research or related operations with budget/CTRAs experience.
• Strong knowledge of ICH-GCP, EU CTR, IVDR and regulatory requirements.

Responsibilities

• Lead country-level study start-up activities and regulatory submissions.
• Manage local study operations, budgeting and CTRAs negotiations.
• Collaborate with Finance, Legal, Regulatory Affairs and vendors.
• Drive process improvements and SOP contributions.
• Mentor and onboard staff and support local initiatives.

Skills

Budget management

Contract negotiations

ICH-GCP knowledge

Regulatory compliance

Stakeholder management

Cross-functional collaboration

Clinical operations

Portuguese fluency

English fluency

Problem solving

Education

Bachelor's degree in life sciences/related

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:

Bring energy, knowledge, innovation and leadership to carry out the following:

• 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:

In order to excel in this role, you will more than likely have:

• 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.

Additional location(s) Compensation Information:

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}

Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date: 11/2/2026

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R421021