Country Study Operations Manager - FSP

Overview

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Parexel FSP is hiring multiple Country Study Operations Managers (cSOMs) in Chile . The cSOM will be responsible for study and regional or country-level activities from study startup through conduct and study close. The role includes managing study management tasks for assigned studies of limited complexity or a unique part of a larger study, and collaborating with Global Study Managers, other Study Operational Managers and the broader Study Management team. The cSOM may partner with various stakeholders to ensure a coordinated approach to study startup, execution and close out.

The cSOM has comprehensive knowledge in managing and coordinating specific tasks as part of the larger Study Management team and may lead specific parts of the project or drive specific countries. They provide local intelligence and updates to support critical path activities and risk management, ensuring operational delivery in accordance with quality standards (ICH / GCP), SOPs, local guidelines and regulatory requirements.

Responsibilities

• Regional / Country / Study level implementation of Startup and Site Activation Plans (through SUPM or pCRO if assigned)
• Regional / Country / Study level Recruitment Strategy
• Support development of study level plans and ensure efficient and timely study delivery
• Communicate with local teams, internal stakeholders and pCRO to coordinate delivery
• Oversee study and / or country vendor management and oversight
• Coordinate follow-up of regional / site quality events, data issues, risks, audits and related actions
• Work independently, providing judgment and guidance as needed

Role Responsibilities

Basic Qualifications

Seniority level

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