Clinical Operations Lead: Country Trials & Compliance

MSD; Lisboa; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

MSD Portugal is seeking a Clinical Operations Manager to ensure performance, compliance and execution of country-specific trial protocols under ICH-GCP. You will lead country start-up activities and oversee budget, CTRAs and regulatory communications.

Collaborate with Finance, Legal, Regulatory and Pharmacovigilance, coordinate with sites, and mentor local teams while driving process improvements. Fluency in Portuguese and English is required, with 5+ years in clinical research or operations.

Qualifications

• Bachelor’s degree in Life Sciences, Business Administration, Finance, Healthcare or related discipline.
• Minimum 5 years of experience in clinical research or a mix of clinical research and finance/operations.
• Strong knowledge of clinical trial regulations, ICH-GCP and local regulatory requirements.
• Experience in budget management, CTRAs negotiations, and financial compliance.
• Understanding of EU CTR and IVDR.
• Excellent problem-solving and communication skills with cross-functional collaboration.

Responsabilités

• Lead country-level study start-up activities, including submissions, approvals, ethics interactions and regulatory authority communications.
• Manage local study operations including informed consent, supplies, import/export, archiving and insurance processes.
• Own country/site budget management, financial compliance, payments, and CTRAs development and execution.
• Collaborate with Finance, Legal, Regulatory Affairs and Pharmacovigilance, plus external vendors for timely milestones.
• Drive process improvements, contribute to SOPs and act as SME for operational topics.
• Mentor and onboard staff while supporting strategic local initiatives and projects.

Connaissances

Budget management

Contract negotiations

CTRAs

ICH-GCP

Regulatory knowledge

Stakeholder management

Cross-functional collaboration

Problem solving

Bilingual PT/EN

Formation

Life Sciences degree

Business Administration degree

Finance degree

Healthcare related degree

Outils

Clinical systems

Digital technologies

AI-enabled tools

Description du poste

MSD Portugal is seeking a Clinical Operations Manager to ensure performance, compliance and execution of country-specific trial protocols under ICH-GCP. You will lead country start-up activities and oversee budget, CTRAs and regulatory communications.

Collaborate with Finance, Legal, Regulatory and Pharmacovigilance, coordinate with sites, and mentor local teams while driving process improvements. Fluency in Portuguese and English is required, with 5+ years in clinical research or operations.