Clinical Operations Lead

This is a fully remote position, open to applicants in Poland.

📋 Description

• Supervision of a team of study CRAs to ensure compliance with study protocols, plans, ICH-GCP, local regulations, and study timelines at sites.

• Conduct monitoring support visits (Accompanied site visits) as required by the project to assist the site/CRA in meeting performance and compliance standards.

• Create training materials and study tools for sites and CRAs, which include monitoring plans.

• Collaborate with the clinical project team to develop and implement strategies for enrolment and recruitment.

• Provide oversight of study deliverables related to various functions (e.g., Data Management, TMF Operations, etc.) to support the clinical project team.

• Actively manage site and country performance (recruitment, data collection, document collection, TMF review, timely updates of Biomapas/sponsor CTMS by study CRAs, etc.) and communicate progress to the clinical project team.

• Oversee regional startup and feasibility initiatives.

• Deliver project training and mentoring to regional CRAs concerning study procedures, clinical plans and guidelines, and timelines.

• Assist in vendor management activities as needed for the project.

• Review visit reports for quality, compliance, and effective site management.

• Ensure adherence to high-quality and timely project deliverables in accordance with project requirements and the monitoring plan.

⛳️ Requirements

• Bachelor’s or Master’s Degree in Medicine, Pharmacy, or Life Sciences.

• A minimum of 3 years of experience in a Clinical Lead role.

• Proficiency in written and spoken English.

• Strong coordination abilities.

• Excellent attention to detail, time management, and problem-solving skills.

• Robust organizational and analytical skills.

🏝️ Benefits

• Opportunities for professional growth and career advancement.

• Work within an international team and environment.

• Performance-based bonus on an annual basis.

• Personal accident and business trip insurance coverage.

• Additional health insurance provided.

• Remote or home-based working options available.

• Complimentary health and wellness benefits, including influenza vaccinations.

• Attractive referral policy rewards.

• Workplace establishment allowance for fully remote positions.

• Team-building activities, global meetings, and B active events.