Clinical Operations Manager

MSD Portugal; Oeiras; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

MSD Portugal is seeking a Clinical Operations Manager to lead country-level trial start-up, budget management, and regulatory compliance. The role collaborates with Finance, Legal, and Regulatory teams and external vendors to ensure timely delivery of milestones and strong operational performance.

The ideal candidate has 5+ years in clinical research or related operations, with a solid grasp of ICH-GCP, CTRAs, and EU regulations, and is fluent in English and Portuguese.

Qualifications

• Bachelor's degree in Life Sciences, Business Administration, Finance, Healthcare, or 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 CTRAs.
• Understanding of EU CTR and IVDR regulations.
• Excellent problem-solving and critical thinking with risk identification and mitigation.
• Strong communication and cross-functional collaboration skills.
• Proficiency in clinical systems, digital technologies, and AI-enabled tools.
• Fluent written and verbal English and Portuguese skills.

Responsabilités

• Lead country-level study start-up activities, including submissions, approvals, ethics committee interactions, and regulatory communications.
• Manage local study operations, including informed consent, supplies, archiving, and compliance documentation.
• Own country and site budget management, financial compliance, payment processes, and CTRAs.
• Collaborate with Finance, Legal, Regulatory Affairs, Pharmacovigilance and external vendors to meet milestones.
• Drive process improvements and contribute to local SOPs; act as SME for operational topics.
• Mentor and onboard junior staff; contribute to strategic local initiatives.

Connaissances

Budget management

Negotiation

Stakeholder management

Cross-functional collaboration

Problem solving

English fluency

Portuguese fluency

Formation

Bachelor's degree

Outils

Clinical systems

AI-enabled tools

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

• 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.

Flexible Work Arrangements: Not Applicable