Clinical Operations Lead — Start-Up, Budget & Compliance

MSD Portugal; Oeiras; On-site; EUR 90,000 - 120,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Budget management

Negotiation

Stakeholder management

Cross-functional collaboration

Problem solving

English fluency

Portuguese fluency

Education

Bachelor's degree

Tools

Clinical systems

AI-enabled tools

Job description

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.