Parexel - King of Prussia, PA
posted about 2 months ago
The Local Study Associate Director (FSP) at Parexel International Corporation is responsible for overseeing the commitments of clinical studies within the country, ensuring timely delivery of high-quality data. This role involves leading the Local Study Team, which includes Clinical Research Associates (CRAs) and Clinical Study Associates (CSAs), to optimize their performance while ensuring compliance with CLIENT Procedural Documents, ICH-GCP, and local regulations. The Associate Director will coordinate the site selection process, conducting feasibility assessments, and ensuring that all necessary documentation is submitted to Ethics Committees (EC) and Institutional Review Boards (IRB) in a timely manner. In addition to managing the study commitments, the Associate Director will prepare and maintain the financial Study Management Agreement (fSMA) and oversee the budget for clinical studies. They will also be responsible for preparing the Master Informed Consent Form (MICF) and ensuring that all essential trial documents are collected and verified before the study begins. The role requires planning and coordinating local drug activities, maintaining the study in the Clinical Trial Management System (CTMS), and managing monitoring activities from site activation to study closure. The Associate Director will proactively identify risks and resolve complex study issues, organize regular meetings with the Local Study Team, and maintain good relationships with team members, site staff, and global stakeholders. They will report study progress to the Global Study Associate Director and contribute to patient recruitment strategies. The role also involves developing and reviewing risk management plans, ensuring compliance with local policies and ethical standards, and participating in training new team members. Overall, this position plays a critical role in ensuring that clinical trials are conducted efficiently and in compliance with all regulatory requirements.