Clinical Operations Director

hace 2 semanas


Pájaros Barrio, Puerto Rico Lancesoft A tiempo completo

Clinical Operations Director

At Lancesoft, we are seeking a highly skilled Clinical Operations Director to lead the development, optimization, and implementation of clinical trial processes across our organization. This is a key role that requires a deep understanding of international GCP regulatory requirements and end-to-end clinical trial processes.

Key Responsibilities:

Develop and optimize clinical trial processes to ensure compliance with regulatory requirements

Partner with cross-functional teams to identify and lead process improvement opportunities

Establish and maintain training curricula for clinical operations and support other clinical development functions

Develop onboarding plans for clinical operations and support transition planning as needed

Proactively monitor compliance with clinical operations procedural documents and training requirements

Develop and report process and training compliance metrics

Support internal audits and regulatory authority inspections as needed

Maintain awareness of changes within the industry and regulatory environment to ensure clinical development processes are updated as necessary

Requirements:

In-depth knowledge of international GCP regulatory requirements

Deep understanding of end-to-end clinical trial processes

Excellent communication and leadership skills

Ability to prioritize and adjust workload to meet evolving department and regulatory needs



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