Clinical Operations Manager

Há 6 dias

lisboa, distrito de lisboa, Portugal MSD Portugal Tempo integral

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,