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Clinical Operations Lead

AlimentivBudapest
On-site Full-time

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Experience Level

Experience

Qualifications

Ideal candidates should possess a solid background in clinical operations, with demonstrated experience in project management within the clinical research environment. A thorough understanding of GCP, ICH guidelines, and regulatory requirements is essential. Strong leadership and communication skills are crucial, along with the ability to train and mentor CRAs effectively. A proactive approach to problem-solving and a commitment to maintaining high standards of quality in clinical operations are key attributes for success in this role.

About the job

As the Clinical Operations Lead, you will play a pivotal role in overseeing clinical operations for projects at a regional and global level. You will ensure that project deliverables, in alignment with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines, and local regulations, are met efficiently. Acting as the primary liaison between Clinical Research Associates (CRAs) and the clinical project team, you will provide essential oversight and direction. Your responsibilities will include project-specific training for CRAs, conducting assessment visits, implementing effective enrollment and recruitment strategies, preparing monitoring plans, and managing documentation. Additionally, you will oversee monitoring visit scheduling, track site performance metrics, escalate issues, and implement corrective actions. You will also develop study tools for CRAs and site use, review visit reports, and monitor protocol deviations to support the objectives of the clinical project team.

About Alimentiv

Alimentiv is a prominent global provider of clinical research services, dedicated to improving patient outcomes through innovative research solutions. Our team is committed to excellence and integrity, working collaboratively with clients to deliver high-quality clinical trials and research data.

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