Clinical Operations Lead: Startups, Budgets & Compliance

Merck Gruppe - MSD Sharp & Dohme; Lisboa; Hybride; EUR 70 000 - 100 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Budget management

Contract negotiations

ICH-GCP knowledge

Regulatory compliance

Stakeholder management

Cross-functional collaboration

Clinical operations

Portuguese fluency

English fluency

Problem solving

Formation

Bachelor's degree in life sciences/related

Description du poste

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.