Clinical Operations Manager

MSD; Oeiras; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

MSD in Portugal seeks a Clinical Operations Manager to ensure performance, compliance, and execution of country-level clinical trial protocols per ICH-GCP.

You will drive study start-up, regulatory submissions, financial management, and operational delivery, coordinating with investigators, vendors and regulatory authorities to ensure milestones are met.

Qualifications

• Bachelor's degree in Life Sciences, Business Administration, Finance, Healthcare, or related field.
• Minimum 5 years of experience in clinical research or a mix 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 CTRAs.
• Solid understanding of EU CTR and IVDR regulatory frameworks.
• Excellent problem-solving and critical thinking with risk identification and mitigation.
• Strong communication, stakeholder management, negotiation, and cross-functional collaboration skills.
• Proficiency in clinical systems, digital technologies, and AI-enabled tools supporting clinical operations.
• Fluent written and verbal Portuguese and English.

Responsabilités

• Lead and oversee country-level study start-up activities, including submissions, approvals, ethics interactions, and regulatory communications.
• Manage local study operations including informed consent, supplies, archiving, and compliance documentation.
• Own country and site budget management, CTRAs, and financial compliance processes.
• Collaborate with Finance, Legal, Regulatory, Pharmacovigilance, and vendors to ensure timely milestones.
• Drive process improvements and contribute to local SOPs as SME for operations.
• Support talent development through mentoring and onboarding, and contribute to strategic local initiatives.

Connaissances

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

CTA

Formation

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

Description du poste

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:

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.

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}

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. So, if you are ready to contribute to the delivery of innovative clinical research and make a meaningful impact on patients' lives.

Job Posting End Date: 11/2/2026

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

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.