Senior Clinical Research Associate II

Role: Senior Clinical Research Associate II responsible for site management and monitoring in clinical trials to ensure patient safety, data quality, and compliance with GCP and Pfizer standards. Objectives include effective site oversight from initiation to close-out, maintaining investigator relationships, supporting enrollment and study progress, and ensuring regulatory adherence. Responsibilities encompass onsite and remote monitoring, issue resolution, safety reporting, documentation, training, and facilitating audit readiness. They also involve mentoring junior staff, supporting global trial processes, and managing investigational product oversight.

Qualifications: Bachelor's degree in life sciences or related field; minimum of 5 years of clinical research site monitoring experience, with at least 3 years in Oncology preferred. Extensive knowledge of GCP, ICH, FDA regulations, and global trial processes. Fluency in English and relevant local languages, with strong communication, leadership, and regulatory interaction skills.

High-Value specifics: Focus on oncology, vaccines, infectious diseases, or internal medicine with experience in global clinical trials. Role involves significant travel (60-80%), including international travel, and requires a valid passport and driver's license. The position demands deep understanding of clinical trial methodologies, safety, data management, and investigator engagement within a regulated environment.